QUALITY CHOICE EXTRA STRENGTH PAIN RELIEF- acetaminophen tablet 
Chain Drug Marketing Association

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

Acetaminophen


Purpose

Pain reliever/fever reducer

Uses

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dosse of this product is 6 caplets (3,000 mg) in 24 hours. Severe liver damage may occur if you take:

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

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 damamge. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Other Information


Inactive Ingredients  

Polyvinylpyrrolidone, pregelatinized starch, sodium starch glycolate, stearic acid

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QUALITY CHOICE EXTRA STRENGTH PAIN RELIEF 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-978
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE K30 (UNII: U725QWY32X)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize12mm
FlavorImprint Code PH044
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-978-081 in 1 CARTON
18 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34308/23/2014
Labeler - Chain Drug Marketing Association (011920774)
Registrant - Reese Pharmaceutical Co (004172052)
Establishment
NameAddressID/FEIBusiness Operations
Reese Pharmaceutical Co004172052relabel(63868-978) , repack(63868-978)
Establishment
NameAddressID/FEIBusiness Operations
Pharbest557054835manufacture(63868-978)

Revised: 8/2014
Document Id: 0d58dfa3-1dd3-4074-ad83-3aae6b6bb5f0
Set id: 7198fefd-b95b-4c8e-b70a-5ea061098baa
Version: 1
Effective Time: 20140823
 
Chain Drug Marketing Association