EXTRA STRENGTH PAIN RELIEF- acetaminophen capsule, gelatin coated 
Geri-Care Pharmaceutical Corp

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251

Active ingredient (in each gelcap)

Acetaminophen 500 mg

Purpose

Pain Reliever/Fever Reducer

Uses

Warnings

Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take:
• more than 8 gelcaps (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 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

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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

6 hours, as needed; not more than 6 gelcaps in 24 hours.
Do not take for more than 10 days unless directed by a doctor.

Other Information

Inactive Ingredients

Croscarmellose Sodium, D and C Red 33, FD and C Blue 1, FD and C Red 40, Gelatin, Hydroxypropyl Cellulose, Hypromellose, Iron Oxide, PEG, Povidone, Propylene Glycol, Shellac Glaze, Starch, Stearic Acid, Titanium Dioxide.

Package label

1

EXTRA STRENGTH PAIN RELIEF 
acetaminophen capsule, gelatin coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-251
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
Colorred (red, gray and blue) Scoreno score
ShapeCAPSULE (Gelcap) Size19mm
FlavorImprint Code L5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57896-251-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/01/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01306/01/2007
Labeler - Geri-Care Pharmaceutical Corp (611196254)
Registrant - Geri-Care Pharmaceutical Corp (611196254)

Revised: 10/2023
Document Id: 08157e2c-2c6f-1487-e063-6394a90a1092
Set id: e65dbd01-2d5e-4067-ad98-98d879cfb5ee
Version: 5
Effective Time: 20231019
 
Geri-Care Pharmaceutical Corp