PAIN RELIEVER EXTRA STRENGTH- acetaminophen capsule, liquid filled 
Mckesson (Sunmark)

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 500 mg

Purpose

Pain reliever/ fever reducer

Uses

for the temporarily relief of minor aches and pains associated with: 

Warnings

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

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 right away: 1-800-222-1222. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Do not exceed recommended dose

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 this product

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 out of reach of children.

Directions

Other information

Inactive ingredients

aerosil 200, D&C Yellow #10, edible ink, gelatin, glycerin USP, povidone K- 30 USP, polyethylene glycol 400 NF, polyethylene glycol 600 NF, propylene glycol USP, Purified water USP, sorbitol special GC, and titanium dioxide USP.

Principal Display Panel

Compare to Extra Strength TYLENOL® ACTIVE INGREDIENT*

SEE NEW WARNINGS INFORMATION

PAIN RELIEVER

Extra Strength

pain reliever & fever reducer

ACETAMINOPHEN 500 mg

Questions or comments ?

call toll free 1-877-753-3935

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol®

Product Label

sunmark apap extra strength

Extra strength Pain Reliever

PAIN RELIEVER  EXTRA STRENGTH
acetaminophen capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-709
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POVIDONES (UNII: FZ989GH94E)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color YELLOW Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code APAP500
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49348-709-59 1 in 1 CARTON
1 40 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 07/09/2010
Labeler - Mckesson (Sunmark) (177667227)

Revised: 9/2012
Document Id: 73b0825f-fe9b-43fb-b1ed-7ce95b33e0e0
Set id: c6dbb88d-371c-4823-a8af-39c011905668
Version: 1
Effective Time: 20120917
 
Mckesson (Sunmark)