Drug Labeling and Warnings

Drug Details

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EXTRA STRENGTH PAIN RELIEVER FEVER REDUCER - acetaminophen liquid 
Family Dollar, 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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Drug Facts

Active ingredient (in each 15 mL)

Acetaminophen USP 500 mg

Purpose

Pain reliever/Fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
  • headache
  • muscular aches
  • backache
  • minor pain of arthritis
  • the common cold
  • toothache
  • premenstrual and menstrual cramps
  • temporarily reduces fever

Warnings

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • 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.

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 have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

liver disease

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep this and all drugs out of the reach of children.

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of accidental overdose, seek professional assistance 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

  • do not take more than directed (see overdose warning)
  • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • mL = milliliter
adults and children 12 years and over
  • take 30 mL in dose cup provided every 4 to 6 hours while symptoms last
  • do not take more than 120 mL in 24 hours
  • do not take more than 10 days unless directed by a doctor
children under 12 years
  • do not use this adult product in children under 12 years of age this will provide more than the recommended dose (overdose) and may cause liver damage

Other information

  • each 15 mL contains: sodium 7 mg
  • store at 20-25° C (68-77° F).
  • dosage cup provided
  • do not use if printed shrinkband is missing or broken.

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, D&C Red 33, FD&C red 40, flavors, high fructose corn syrup, non-crystallizing sorbitol solution, polyethylene glycol, propylene glycol, purified water, sodium benzoate, and sucralose. 

Questions or comments?

1-866-377-6420

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

DISTRIBUTED BY:
FAMILY DOLLAR SERVICES, INC.,
10401 MONROE RD,
MATTHEWS, NC 28105 USA
MADE IN THE U.S.A.

Not 100% Satisfied? Return package and unused product within 30 days to any Family Dollar store for a refund (with receipt) or exchange.

Visit FamilyDollar.com

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (237 mL)

NDC: 55319-997-20
COMPARE TO THE ACTIVE INGREDIENTS
IN TYLENOL® EXTRA STRENGTH
ADULT RAPID BLAST CHERRY*
FAMILY
WELLNESSTM
Extra Strength
Rapid Burst
Pain Reliever
Fever Reducer
Adult Acetaminophen oral Liquid 500 mg/15 mL
8 FL OZ
(237 mL)
CHERRY FLAVOR
DO NOT USE IF PRINTED SHRINK BAND IS MISSING OR BROKEN.

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (118 mL)

EXTRA STRENGTH PAIN RELIEVER FEVER REDUCER 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55319-997
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
CHERRY (UNII: BUC5I9595W)  
MENTHOL (UNII: L7T10EIP3A)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
SORBITOL (UNII: 506T60A25R)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRY, MENTHOLImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55319-997-201 in 1 CARTON10/08/2015
1237 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34310/08/2015
Labeler - Family Dollar, Inc. (024472631)
Establishment
NameAddressID/FEIBusiness Operations
Aurohealth LLC078728447MANUFACTURE(55319-997)

Revised: 5/2016
 
Family Dollar, Inc.


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