FAMILY DOLLAR DAYTIME COLD AND FLU RELIEF- acetaminohpen, dextromethorphan hbr, 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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Family Dollar DayTime Cold and Flu Relief

Active ingredients (in each 15 mL)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

 
temporarily relieves common cold/flu symptoms:
 

Warnings

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

adult takes more than 4 doses (30 mL) in 24 hours which is maximum daily amount for this product
child takes more than 4 doses (15 mL) in 24 hours, 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 followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

with any other drug containing acetaminophen (prescription or non-prescription). 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 an enlarged prostate gland
cough that occurs with too much phlegm (mucus)
persistent or chronic cough such as occurs with smoking, asthma, or emphysema
a sodium-restricted diet

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 a 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 (1-800-222-1222) right away. 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 hours

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 42 mg 
store at room temperature. Do not refrigerate

Inactive ingredients

Anhydrous citric acid, disodium edetate, FD&C Yellow No 6, flavor, glycerin, menthol, potassium citrate, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium chloride, sorbitol, sucralose, xanthan gum

Questions or comments?

1-866-467-2748

Principal Display Panel

Compare to the active ingredients in Vicks® Dayquil™ Cold & Flu*

NDC 55319-912-12

Day Time

Cold & Flu Relief 

Acetaminophen, Phenylephrine HCI,

Dextromethorphan HBr

Headache, Fever, Sore Throat, Minor Aches & Pains
Nasal congestion & Sinus Pressure
Cough

12 FL OZ (354 mL)

DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN

Distributed by:

*This product.is not manufactured or distributed by Procter & Gamble, the distributor of Vicks® Dayquil™ Cold & Flu.

Family Dollar Daytime Cold & Flu Relief  12 Fl oz (354 mL)
FAMILY DOLLAR DAYTIME COLD AND FLU RELIEF 
acetaminohpen, dextromethorphan hbr, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-912
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
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
POTASSIUM CITRATE ANHYDROUS (UNII: 86R1NVR0HW)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55319-912-12354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/07/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/07/2023
Labeler - FAMILY DOLLAR SERVICES INC (024472631)

Revised: 7/2023
Document Id: cef63000-9df2-4312-afbd-f932d7ebc112
Set id: cef63000-9df2-4312-afbd-f932d7ebc112
Version: 1
Effective Time: 20230726
 
FAMILY DOLLAR SERVICES INC