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NDC 62011-0437-01 health mart day time cold and flu night time cold and flu Details

health mart day time cold and flu night time cold and flu

health mart day time cold and flu night time cold and flu is a KIT in the HUMAN OTC DRUG category. It is labeled and distributed by Strategic Sourcing Services LLC. 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: 62011-0437-01
Last Updated: 12/01/2022
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: 62011-0437-01
Last Updated: 12/01/2022
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: 62011-0437-01
Last Updated: 12/01/2022
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: 62011-0437-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine

Product Information

NDC	62011-0437
Product ID	62011-0437_c6d22c2d-e5f0-429d-870b-684bf5f8b8e9
Associated GPIs
GCN Sequence Number	065258
GCN Sequence Number Description	DM/PE/acetaminophen/doxylamine CAP SEQ 10-5-325MG ORAL
HIC3	B3P
HIC3 Description	NON-OPIOID ANTITUS-1STGEN ANTIHIST-DECON-ANALGESIC
GCN	24902
HICL Sequence Number	033966
HICL Sequence Number Description	DEXTROMETHORPHAN HBR/PHENYLEPHRINE/ACETAMINOPHEN/DOXYLAMINE
Brand/Generic	Generic
Proprietary Name	health mart day time cold and flu night time cold and flu
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	Strategic Sourcing Services LLC
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 62011-0437-01 (62011043701)

Pricing Information	N/A
NDC Package Code	62011-0437-1
Billing NDC	62011043701
Package	1 KIT in 1 CARTON (62011-0437-1) * 8 BLISTER PACK in 1 CARTON / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 16 BLISTER PACK in 1 CARTON / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date	2020-01-22
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c6d22c2d-e5f0-429d-870b-684bf5f8b8e9 Details

Active ingredients (in each softgel) – Nighttime Cold & Flu

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Active ingredients (in each softgel) – Daytime Cold & Flu

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose – Nighttime Cold & Flu

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Purpose – Daytime Cold & Flu

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses – Nighttime Cold & Flu

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

Uses – Daytime Cold & Flu

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 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, lasts 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 – Nighttime Cold & Flu

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

Ask a doctor before use if you have – Daytime Cold & Flu

•: liver disease
•: heart disease
•: high blood pressure
•: thyroid disease
•: diabetes
•: 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 – Nighttime Cold & Flu

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

Ask a doctor or pharmacist before use if you are – Daytime Cold & Flu

taking the blood thinning drug warfarin

When using this product – Nighttime Cold & Flu

•: 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

When using the product – Daytime Cold & Flu

do not use more than directed

Stop use and ask a doctor if – Nighttime Cold & Flu

•: 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.

Stop use and ask a doctor if – Daytime Cold & Flu

•: you get nervous, dizzy or sleepless
•: pain, nasal congestion 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 – Nighttime Cold & Flu

•: take only as directed – see overdose warning
•: do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over	2 softgels with water every 6 hrs
children 4 to under 12 yrs	ask a doctor
children under 4 yrs	do not use

Directions – Daytime Cold & Flu

•: take only as directed – see overdose warning
•: do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over	2 softgels with water every 4 hrs
children 4 to under 12 yrs	ask a doctor
children under 4 yrs	do not use

Other information

•: store at 20-25°C (68-77°F)

Inactive ingredients – Nighttime Cold & Flu

D&C yellow no. 10, edible ink*, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

Inactive ingredients – Daytime Cold & Flu

edible ink*, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to Vicks® DayQuil® Cold & Flu active ingredients

DAYTIME RELIEF

DayTime Cold & Flu

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl

Pain Reliever/Fever Reducer, Cough Suppressant, Nasal Decongestant

For Relief of:

Aches/Fever/Sore Throat

Nasal Congestion – Cough

Alcohol Free

Antihistamine Free

Gluten Free

Actual Size

32 Softgels

Compare to Vicks® NyQuil® Cold & Flu active ingredients

NIGHTIME RELIEF

NightTime Cold & Flu

Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate

Pain Reliever/Fever Reducer, Cough Suppressant, Antihistamine