FAMILY DOLLAR NIGHTTIME COLD AND FLU RELIEF ORIGINAL FLAVOR- acetaminophen, dextromethorphan hbr, doxylamine succinate solution

Family Dollar Nighttime Cold and Flu Relief by

Drug Labeling and Warnings

Family Dollar Nighttime 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]

Active ingredients (in each 30 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses

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

Warnings

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

• more than 4 doses in 24 hours, which is the maximum daily amount for this product
• 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, 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.

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

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

When using this product

• ▪ 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

Stop use and ask a doctor if

•  
  • ▪ 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.

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
• only use the dose cup provided
• do not exceed 4 doses per 24 hrs

• adults & children 12 yrs & over:

  30 mL every 6 hrs

• children 4 to under 12 yrs:

  ask a doctor

• children under 4 yrs:

  do not use

Other information

• each 30 mL contains: sodium 16 mg
• store at room temperature and do not refrigerate

Inactive ingredients

anhydrous citric acid, D&C Yellow No. 10, disodium edetate, FD&C Green No. 3, FD & C Yellow No 6, flavors, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol liquid, sucralose.

Questions or comments?

1-866-467-2748

Package/Label Principal Display Panel

Compare to the active ingredients in VICKS® Nyquil™Cold & Flu*

NDC: 55319-692-12

Nighttime Cold & Flue Relief

Acetaminophen, Dextromethorphan succinate,

Doxylamine HBr

• Headache, Fever, Sore Throat, Minor Aches & Pains
• Sneezing, Runny Nose
• Cough

Original Flavor

12 FL OZ (354 mL)

TAMPER EVIDENT: 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® Nyquil™Cold & Flu*

INGREDIENTS AND APPEARANCE

FAMILY DOLLAR NIGHTTIME COLD AND FLU RELIEF  ORIGINAL FLAVOR
acetaminophen, dextromethorphan hbr, doxylamine succinate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-692
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg  in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	12.5 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
PROPYL GALLATE (UNII: 8D4SNN7V92)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-692-12	354 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/10/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	07/10/2023

Labeler - FAMILY DOLLAR SERVICES INC (024472631)