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Extra Strength Pain Relief by Chain Drug Consortium, LLC

Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 500mg
Labeler: Chain Drug Consortium, LLC
NDC Code: 68016-029

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.

premier value 251

Active ingredient

Acetaminophen 500 mg

Purpose


Pain Reliever/Fever Reducer

Uses
  • temporarily relieves minor aches and pains due to:
  • - headache
  • - muscular aches
  • - backache
  • - arthritis
  • - the common cold
  • - toothache
  • - menstrual cramps

  • 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.

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.

Keep out of reach of children.

Directions
  • Do not take more than directed (see overdose warnings)
    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 yearsDo not use

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

Inactive Ingredients

croscarmellose sodium, D&C Red #33, FD&C Blue #1, FD&C Red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide, PEG, povidone, propylene glycol, shellac glaze, starch, stearic acid, titanium dioxide.

package label

NDC 68016-029-47

Compare to active ingredient in Extra Strength Tylenol Rapid Release Gels*

Extra Strength

PAIN RELIEF

ACETAMINOPHEN

Rapid Release

Pain Reliever/ Fever Reducer

Gelcaps

400 Gelcaps

500 mg each

EXTRA STRENGTH PAIN RELIEF 
acetaminophen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-029
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 
GELATIN 
POLYETHYLENE GLYCOLS 
POVIDONES 
PROPYLENE GLYCOL 
STARCH, CORN 
STEARIC ACID 
TITANIUM DIOXIDE 
FD&C RED NO. 40 
HYDROXYPROPYL CELLULOSE (TYPE H) 
HYPROMELLOSES 
FERRIC OXIDE RED 
SHELLAC 
Product Characteristics
Colorred (with blue and a gray band) Scoreno score
ShapeCAPSULE (Gelcap) Size19mm
FlavorImprint CodeL;5
Contains    
Packaging
#Item CodePackage Description
1NDC:68016-029-201 BOTTLE in 1 CARTON
1100 TABLET, COATED in 1 BOTTLE
2NDC:68016-029-141 BOTTLE in 1 CARTON
250 TABLET, COATED in 1 BOTTLE
3NDC:68016-029-47400 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34309/01/2007
Labeler - Chain Drug Consortium, LLC (101668460)
Registrant - Geri-Care Pharmaceutical Corp (611196254)
Establishment
NameAddressID/FEIOperations
Geri-Care Pharmaceutical Corp611196254repack(68016-029)

 
Chain Drug Consortium, LLC

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Medically reviewed on Oct 22, 2018

Further information

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

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