QAULITY CHOICE PAIN RELIEF EXTRA STRENGTH- acetaminophen liquid 
CHAIN DRUG MARKETING ASSOCIATION 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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Active Ingredient

Acetaminophen 500 mg

Purpose

Pain Reliever/Fever Reducer

Uses

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 tablespoonfuls in 24 hours. Sever liver damage may occur if you take

Allergy alert: acetaminophen may cause sever skin reactions. Symptoms may include:

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 allergic to acetaminophen or any of the inactive ingredients in thris product.
Ask a doctor before use if you have liver disease
Ask a doctor before use if you are taking the blodd thinning drug warfarin.
When using this product: Do not exceed recomended dose.
Stop use and ask a doctor if:

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 midcal help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms.

Directions Do not take more than directed

 Age Dose
 Adults and children12 years of age and older Take 1 to 2 tablespoonfuls every 4 to 6 hours as needed. not more than 6 tablespoonfuls in 24 hours
 Children under 12 years Do not use

Inactive ingredients: artificial and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, polyethylene glycol, propylene glycol, porpylparaben, purified water, sodium citrate, sucralose.

Question or comments? 1-800-540-3765

image description

QAULITY CHOICE PAIN RELIEF EXTRA STRENGTH 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-564
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)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-564-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34312/01/2020
Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)

Revised: 12/2020
Document Id: c0c8e3f6-2940-4c0e-9c63-350dc0be5c53
Set id: 5017f066-5642-44df-b57b-a827e7dd4f20
Version: 1
Effective Time: 20201223
 
CHAIN DRUG MARKETING ASSOCIATION INC