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NDC 49348-0753-37 Sunmark Day time 325; 10; 5 mg/15mL; mg/15mL; mg/15mL Details

Sunmark Day time 325; 10; 5 mg/15mL; mg/15mL; mg/15mL

Sunmark Day time is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Strategic Sourcing Services LLC. The primary component is ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE.

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: 49348-0753-37
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: 49348-0753-37
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan

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: 49348-0753-37
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine

Product Information

NDC	49348-0753
Product ID	49348-753_ea76c696-5497-4282-9865-2a9b1fc19a02
Associated GPIs	43996903400910
GCN Sequence Number	061337
GCN Sequence Number Description	d-methorphan/PE/acetaminophen LIQUID 5-325MG/15 ORAL
HIC3	B4M
HIC3 Description	NON-OPIOID ANTITUSSIVE-DECONGESTANT-ANALGESIC COMB
GCN	97129
HICL Sequence Number	008885
HICL Sequence Number Description	DEXTROMETHORPHAN HBR/PHENYLEPHRINE HCL/ACETAMINOPHEN
Brand/Generic	Generic
Proprietary Name	Sunmark Day time
Proprietary Name Suffix	cold and flu
Non-Proprietary Name	acetaminophen, dextromethorphan HBr, Phenylephrine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	325; 10; 5
Active Ingredient Units	mg/15mL; mg/15mL; mg/15mL
Substance Name	ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Labeler Name	Strategic Sourcing Services LLC
Pharmaceutical Class	Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 49348-0753-37 (49348075337)

Pricing Information
NDC Package Code	49348-753-37
Billing NDC	49348075337
Package	237 mL in 1 BOTTLE (49348-753-37)
Marketing Start Date	2012-09-06
NDC Exclude Flag	N
Price Per Unit	0.01263
Pricing Unit	ML
Effective Date	2024-02-21
NDC Description	SM DAY TIME COLD-FLU LIQUID
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 5
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL b859400f-c649-49c3-b5b9-6310c1e78274 Details

Active 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.

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 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

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?

1-800-719-9260

Principal Display Panel

COMPARE TO VICKS® DAYQUIL® COLD & FLU ACTIVE INGREDIENTS

day time

Cold & Flu

Pain Reliever/Fever Reducer

Cough Suppressant

Nasal Decongestant

Acetaminophen

Phenylephrine HCl

Dextromethorphan HBr

Non-Drowsy - Alcohol Free

MULTI-SYMPTOM RELIEF

GLUTEN FREE

8 FL OZ (237 mL)

INGREDIENTS AND APPEARANCE

SUNMARK DAY TIME COLD AND FLU

acetaminophen, dextromethorphan hbr, phenylephrine hcl solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49348-753
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)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCROSE (UNII: C151H8M554)
XANTHAN GUM (UNII: TTV12P4NEE)

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	NDC:49348-753-36	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/09/2006	05/14/2013
2	NDC:49348-753-37	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/06/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	06/09/2006

Labeler - Strategic Sourcing Services LLC (116956644)

Revised: 5/2020

Document Id: ea76c696-5497-4282-9865-2a9b1fc19a02

Set id: b859400f-c649-49c3-b5b9-6310c1e78274

Version: 7

Effective Time: 20200527