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Cold and Flu Nighttime by Family Dollar (FAMILY WELLNESS)

Dosage form: liquid
Ingredients: ACETAMINOPHEN 500mg in 15mL, DEXTROMETHORPHAN HYDROBROMIDE 15mg in 15mL, DOXYLAMINE SUCCINATE 6.25mg in 15mL
Labeler: Family Dollar (FAMILY WELLNESS)
NDC Code: 55319-346

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.

Drug Facts

Active ingredients (in each 15 mL)

Acetaminophen 500 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.5 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses

temporarily relieves these common cold/flu symptoms:

  • minor aches and pains
  • headache
  • sore throat
  • fever
  • runny nose and sneezing
  • itchy nose or throat
  • coughs
  • cough due to minor throat and bronchial irritation

Warnings

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

  • more than 4 doses (120 mL) in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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
  • to make a child sleepy
  • 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.
  • 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 allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if you have
  • liver disease
  • glaucoma
  • breathing problems
  • chronic bronchitis
  • a sodium-restricted diet
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma or emphysema or if cough is accompanied by excessive phlegm (mucus)

Ask a doctor or pharmacist before use if you are taking
  • sedatives or tranquilizers
  • the blood thinning drug warfarin

When using this product
  • do not use more than directed (see overdose warning)
  • 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
  • redness or swelling is present
  • new symptoms occur
  • fever gets worse or lasts more than 3 day
  • pain or cough gets worse or lasts more than 7 days
  • 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: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. 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 recommended (see overdose warning)
  • do not exceed 4 doses in any 24-hour
  • use dosage cup provided
  • mL= milliliter
 agedose
adults & children 12 years and over30 mL every 6 hrs
children 4 to 11 yrsdo not use unless directed by a doctor
children under 4 yrsdo not use
  • When using other Day Time or Night Time products, carefully read each label to ensure correct dosing

Other information
  • each 15 mL contains: sodium 18 mg
  • store at room temperature.

Inactive ingredients

alcohol, citric acid, D&C yellow #10, FD&C green #3, FD&C yellow #6,, flavor,high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST 

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENTS OF VICKS® NYQUIL®*

Nighttime Cold & Flu

Multi-Symptom Relief

Acetaminophen-Pain Reliever/Fever Reducer

Dextromethorphan HBr-Cough Suppressant

Doxylamine Succinate-Antihistamine

FL OZ (mL)

ORIGINAL

ALCOHOL 10 %

*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® NyQuil®.

Failure to follow these warnings could result in serious consequences.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY:

FAMILY DOLLAR SERVICES, INC.,

10401 MONROE RD,

MATTHEWS, NC 28105 USA

VISIT FAMILYDOLLAR.COM

Product Label

Family Wellness NightTime Cold & Flu Original Liquid

COLD AND FLU  NIGHTTIME
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-346
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 15 mL
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE6.25 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL 
WATER 
ALCOHOL 
ANHYDROUS CITRIC ACID 
HIGH FRUCTOSE CORN SYRUP 
POLYETHYLENE GLYCOLS 
SACCHARIN SODIUM 
TRISODIUM CITRATE DIHYDRATE 
D&C YELLOW NO. 10 
FD&C GREEN NO. 3 
FD&C YELLOW NO. 6 
Packaging
#Item CodePackage Description
1NDC:55319-346-10296 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/31/2016
Labeler - Family Dollar (FAMILY WELLNESS) (024472631)

 
Family Dollar (FAMILY WELLNESS)

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Medically reviewed on May 3, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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