DAYTIME COLD AND FLU RELIEF- acetaminophen, dextromethorphan hydrobromide, guaifenesin and phenylephrine hcl liquid 
FAMILY DOLLAR SERVICES INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DayTime Cold & Flu Relief Honey Flavor

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.

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

*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)

DayTime Cold & Flu Relief Honey Flavour 8 FL OZ 236 mL
DAYTIME COLD AND FLU RELIEF 
acetaminophen, dextromethorphan hydrobromide, guaifenesin and phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-610
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 15 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorbrownScore    
ShapeSize
FlavorHONEYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55319-610-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/03/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/03/2023
Labeler - FAMILY DOLLAR SERVICES INC (024472631)

Revised: 7/2023
Document Id: 657bc4f2-8891-4825-852e-12c4b925c393
Set id: 657bc4f2-8891-4825-852e-12c4b925c393
Version: 1
Effective Time: 20230714
 
FAMILY DOLLAR SERVICES INC