DAYTIME COLD AND FLU RELIEF- acetaminophen, dextromethorphan hydrobromide, guaifenesin and phenylephrine hcl liquid

DayTime Cold and Flu Relief by

Drug Labeling and Warnings

DayTime Cold and Flu Relief by is a Otc medication manufactured, distributed, or labeled by FAMILY DOLLAR SERVICES INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredients (in each 15 mL)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant

Expectorant

Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

• nasal congestion
• sinus congestion & pressure
• cough due to minor throat & bronchial irritation
• minor aches & pains
• headache
• fever
• sore throat
• reduces swelling of nasal passages
• temporarily restores freer breathing through the nose
• promotes nasal and/or sinus drainage
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if

• adult takes more than 4 doses (30 mL each) in 24 hrs, which is the maximum daily amount for this product
• child takes more than 4 doses (15 mL each) in 24 hrs, which is the maximum daily amount for this product
• 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 is 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.

Ask a doctor before use if you have

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

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In case of overdose, get medical help or contact a Poison Control Center right away at 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
• 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 9 mg
• Store at room temperature
• Do not refrigerate.

Inactive ingredients

citric acid, D&C Yellow No. 10, edetate disodium, FD&C Green No. 3, FD&C Red No. 40, flavors, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Questions?

1-866-467-2748

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*This product is not manufactured or distributed by Procter & Gamble, distributer of Vicks® Dayquil™ Severe Cold & Flu Honey Flavor

Distributed. by:

PRINCIPAL DISPLAY PANEL - 354 mL Bottle Label

*Compare to the active ingredients in Vicks® DayQuil™ Severe Cold & Flu Honey Flavour

NDC: 55319-610-08

DayTime

Cold & Flu

Relief

Acetaminophen – Pain reliever/Fever reducer

Guaifenesin – Expectorant

Phenylephrine HCl - Nasal decongestant

Dextromethorphan HBr – Cough suppressant

• Headache, Fever, Sore Throat, Minor Aches & Pains
• Chest Congestion,Thins & Loosens Mucus
• Nasal Congestion, Sinus Pressure
• Cough

Honey Flavor

Naturally and Artificially Flavored

8 FL OZ (236 ml)

INGREDIENTS AND APPEARANCE

DAYTIME COLD AND FLU RELIEF 
acetaminophen, dextromethorphan hydrobromide, guaifenesin and phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-610
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor	HONEY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-610-08	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/03/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/03/2023

Labeler - FAMILY DOLLAR SERVICES INC (024472631)