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NDC 49035-0733-02 Equate NiteTime DayTime Details

Equate NiteTime DayTime

Equate NiteTime DayTime is a KIT in the HUMAN OTC DRUG category. It is labeled and distributed by Wal-Mart Stores Inc. The primary component is .

MedlinePlus Drug Summary

Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Related Packages: 49035-0733-02
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen

Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.

Related Packages: 49035-0733-02
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan

Doxylamine is used in the short-term treatment of insomnia (difficulty falling asleep or staying asleep). Doxylamine is also used in combination with decongestants and other medications to relieve sneezing, runny nose, and nasal congestion caused by the common cold. Doxylamine should not be used to cause sleepiness in children. Doxylamine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Related Packages: 49035-0733-02
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Doxylamine

Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.

Related Packages: 49035-0733-02
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine

Product Information

NDC	49035-0733
Product ID	49035-733_3f71bea6-96d8-4b10-bcca-b67276a2c17e
Associated GPIs	43995904186350
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Equate NiteTime DayTime
Proprietary Name Suffix	n/a
Non-Proprietary Name	Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	KIT
Route	n/a
Active Ingredient Strength	n/a
Active Ingredient Units	n/a
Substance Name	n/a
Labeler Name	Wal-Mart Stores Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 49035-0733-02 (49035073302)

Pricing Information	N/A
NDC Package Code	49035-733-02
Billing NDC	49035073302
Package	1 KIT in 1 CARTON (49035-733-02) * 1 BOTTLE in 1 CARTON / 355 mL in 1 BOTTLE * 1 BOTTLE in 1 CARTON / 355 mL in 1 BOTTLE
Marketing Start Date	2013-08-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 971668c3-87bd-4f2c-a52f-5adee45ee46b Details

Nighttime Cold & FluActive ingredients (in each 30 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses

temporarily relieves common cold/flu symptoms:

•: cough due to minor throat and bronchial irritation
•: sore throat
•: headache
•: minor aches and pains
•: fever
•: runny nose and sneezing

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

•: more than 4,000 mg of acetaminophen in 24 hours
•: with other drugs containing acetaminophen
•: 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

•: skin reddening
•: blisters
•: rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

•: with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
•: if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
•: if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

•: liver disease
•: glaucoma
•: cough that occurs with too much phlegm (mucus)
•: a breathing problem such as emphysema or chronic bronchitis
•: trouble urinating due to an enlarged prostate gland
•: persistent or chronic cough as occurs with smoking, asthma, or emphysema
•: a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

•: taking sedatives or tranquilizers
•: taking the blood thinning drug warfarin

When using this product

•: excitability may occur, especially in children
•: marked drowsiness may occur
•: avoid alcoholic drinks
•: be careful when driving a motor vehicle or operating machinery
•: alcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if

•: pain or cough gets worse or lasts more than 7 days
•: fever gets worse or lasts more than 3 days
•: redness or swelling is present
•: new symptoms occur
•: cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

•: take only as directed – see Overdose warning
•: only use the dose cup provided
•: do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over	30 mL every 6 hrs
children 4 to under 12 yrs	ask a doctor
children under 4 yrs	do not use

Other information

•: each 30 mL contains: sodium 39 mg
•: store at 20-25°C (68-77°F)

Inactive ingredients

alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions or comments?

1-888-287-1915

Daytime Cold & FluActive ingredients (in each 15 mL)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

•: nasal congestion
•: cough due to minor throat and bronchial irritation
•: sore throat
•: headache
•: minor aches and pains
•: fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

•: adult takes more than 4,000 mg of acetaminophen in 24 hours
•: child takes more than 5 doses in 24 hours
•: taken with other drugs containing acetaminophen
•: adult has 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

•: skin reddening
•: blisters
•: rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

•: with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
•: if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
•: if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

•: liver disease
•: heart disease
•: thyroid disease
•: diabetes
•: high blood pressure
•: trouble urinating due to an enlarged prostate gland
•: cough that occurs with too much phlegm (mucus)
•: persistent or chronic cough as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

When using this product

do not use more than directed

Stop use and ask a doctor if

•: you get nervous, dizzy or sleepless
•: pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
•: fever gets worse or lasts more than 3 days
•: redness or swelling is present
•: new symptoms occur
•: cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Directions

•: take only as directed – see Overdose warning
•: only use the dose cup provided
•: do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over	30 mL every 4 hrs
children 6 to under 12 yrs	15 mL every 4 hrs
children 4 to under 6 yrs	ask a doctor
children under 4 yrs	do not use

Other information

•: each 15 mL contains: sodium 7 mg
•: store at 20-25°C (68-77°F)

Inactive Ingredients - Daytime

butylated hydroxyanisole, edetate disodium, FD&C yellow no. 6, flavor, glycerin, menthol, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum

Questions or comments?

1-888-287-1915

Principal Display Panel

SEE NEW WARNINGS

Compare to DayQuil® Cold & Flu & NyQuil® Cold & Flu Active Ingredients

Non-Drowsy

DayTime

Cold & Flu

Pain Reliever, Fever Reducer, Cough Suppressant, Nasal Decongestant

Multi-Symptom Relief

Aches, fever – Acetaminophen

Cough – Dextromethorphan HBr

Nasal congestion – Phenylephrine HCl

Alcohol Free and Antihistamine Free

12 FL OZ (355mL)

SEE NEW WARNINGS

Compare to DayQuil® Cold & Flu & NyQuil® Cold & Flu Active Ingredients

NiteTime

Cold & Flu

Pain Reliever, Fever Reducer, Cough Suppressant, Antihistamine

Multi-Symptom Relief

Aches, fever – Acetaminophen

Cough – Dextromethorphan HBr

Sneezing, runny nose – Doxylamine Succinate

10% ALCOHOL

12 FL OZ (355mL)

INGREDIENTS AND APPEARANCE

EQUATE NITETIME DAYTIME

acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-733

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49035-733-02	1 in 1 CARTON; Type 0: Not a Combination Product	08/15/2013

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 BOTTLE	355 mL
Part 2	1 BOTTLE	355 mL

Part 1 of 2
EQUATE NITETIME acetaminophen, dextromethorphan hbr, doxylamine succinate solution

Product Information
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	12.5 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Product Characteristics
Color	RED (Clear/Dark Red)	Score
Shape		Size
Flavor	CHERRY (Menthol Aroma)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		1 in 1 CARTON
1		355 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	08/02/2011

Part 2 of 2
EQUATE DAY TIME COLD AND FLU MULTI SYMPTOM RELIEF acetaminophen, dextromethorphan hbr, phenylephrine hcl solution

Product Information
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg in 15 mL

Ingredient Name	Strength
Inactive Ingredients
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCROSE (UNII: C151H8M554)
XANTHAN GUM (UNII: TTV12P4NEE)
MENTHOL (UNII: L7T10EIP3A)

Product Characteristics
Color	ORANGE (clear)	Score
Shape		Size
Flavor	MENTHOL (with fruit)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		1 in 1 CARTON
1		355 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	06/08/2006

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	08/15/2013

Labeler - Wal-Mart Stores Inc (051957769)

Revised: 12/2018

Document Id: 3f71bea6-96d8-4b10-bcca-b67276a2c17e

Set id: 971668c3-87bd-4f2c-a52f-5adee45ee46b

Version: 4

Effective Time: 20181209

Search by Drug Name or NDC

NDC 49035-0733-02 Equate NiteTime DayTime Details

Equate NiteTime DayTime

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 49035-0733-02 (49035073302)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 971668c3-87bd-4f2c-a52f-5adee45ee46b Details

Nighttime Cold & FluActive ingredients (in each 30 mL)

Purpose

Uses

Warnings

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children

Directions

Other information

Inactive ingredients

Questions or comments?

Daytime Cold & FluActive ingredients (in each 15 mL)

Purpose

Uses

Warnings

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Directions

Other information

Inactive Ingredients - Daytime

Questions or comments?

Principal Display Panel

INGREDIENTS AND APPEARANCE