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Extra Strength Pain Relief by Geri-Care Pharmaceutical Corp

Medically reviewed on May 9, 2018

Dosage form: capsule, gelatin coated
Ingredients: ACETAMINOPHEN 500mg
Labeler: Geri-Care Pharmaceutical Corp
NDC Code: 57896-251

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.

Active ingredient (in each gelcap)

Acetaminophen 500 mg

Purpose

Pain Reliever/Fever Reducer

Uses
  • temporarily relieves minor aches and pains
  • temporarily reduces fever

Warnings

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

* more than 8 gelcaps in 24 hours, which is the maximum daily amount

* with other drugs containing acetaminophen

* 3 or more alcoholic drinks every day while using this product

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.

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 symptom 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
  • Do not take more than directed
  • Adults and children 12 years and over: take 2 gelcaps every 4-6 hours, as needed. Do not take more than 8 gelcaps in 24 hours
  • Children under 12 years: Do not use.

Other Information
  • TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
  • store at 20⁰C-25⁰C (68⁰F-77⁰F)
  • avoid high humidity

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

Gericare

NDC 57896-251-01

Non-aspirin

Extra Strength

PAIN RELIEF

Pain Reliever / Fever Reducer

Compare to active ingredient in Tylenol Extra Strength Rapid Release gels

ACETAMINOPHEN

Rapid Release Gels

100 Gelcaps

500 mg each

EXTRA STRENGTH PAIN RELIEF  
acetaminophen capsule, gelatin coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-251
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
D&C RED NO. 33 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
HYDROXYPROPYL CELLULOSE 
HYPROMELLOSES 
FERROSOFERRIC OXIDE 
POLYETHYLENE GLYCOLS 
POVIDONE 
PROPYLENE GLYCOL 
SHELLAC 
STARCH, CORN 
STEARIC ACID 
TITANIUM DIOXIDE 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
Product Characteristics
Colorred (red, gray and blue) Scoreno score
ShapeCAPSULE (Gelcap) Size19mm
FlavorImprint CodeL5
Contains    
Packaging
#Item CodePackage Description
1NDC:57896-251-01100 CAPSULE, GELATIN COATED (CAPSULE) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34306/01/2007
Labeler - Geri-Care Pharmaceutical Corp (611196254)
Registrant - Geri-Care Pharmaceutical Corp (611196254)

 
Geri-Care Pharmaceutical Corp

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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