COLD AND FLU NIGHTTIME- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid

Cold and Flu by

Drug Labeling and Warnings

Cold and Flu by is a Otc medication manufactured, distributed, or labeled by Family Dollar (FAMILY WELLNESS). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• age: dose
• adults & children 12 years and over: 30 mL every 6 hrs
• children 4 to 11 yrs: do not use unless directed by a doctor
• children under 4 yrs: do 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

INGREDIENTS AND APPEARANCE

COLD AND FLU  NIGHTTIME
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-346
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg  in 15 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-346-10	296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/31/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	03/31/2016

Labeler - Family Dollar (FAMILY WELLNESS) (024472631)