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Pharbetol by Pharbest Pharmaceuticals, Inc.

Medically reviewed on May 14, 2018

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: Pharbest Pharmaceuticals, Inc.
NDC Code: 16103-376

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.

Drug Facts

Active ingredient (in each tablet)Acetaminophen 500mg

PurposePain reliever/fever reducer

UsesTemporarily relieves minor aches and pains due to:
  • headache
  • backache
  • minor pain of arthritis
  • toothache
  • muscular aches
  • menstrual cramps
Temporarily reduces fever

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
  • more than 8 tablets 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
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if you haveliver disease.

Ask a doctor or pharmacist before use if you aretaking 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 the case of overdose, get medical help or contact a Poison Control Center right away.

Directions
  • do not take more than directed (see overdose warning).
  • Adult and Children 12 years and over: take 2 tablets, every 4 to 6 hours while symptoms last. Do not take more than 8 tablets in 24 hours. Do not take for more than 10 days unless directed by a doctor.
  • Children under 12 years: do not use adult extra strength product in children under 12 years of age; this will provide more than recommended dose (overdose) and may cause liver damage.

Inactive ingredientsPovidone, Pregelatinized corn starch, sodium starch glycolate, stearic acid.

Questions?Adverse drug event call: (866) 562-2756

PHARBETOL 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16103-376
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE K30 
STARCH, CORN 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize12mm
FlavorImprint CodePH044
Contains    
Packaging
#Item CodePackage Description
1NDC:16103-376-061 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
150 TABLET (TABLET) in 1 BOTTLE, PLASTIC
2NDC:16103-376-081 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
2100 TABLET (TABLET) in 1 BOTTLE, PLASTIC
3NDC:16103-376-111000 TABLET (TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/10/2006
Labeler - Pharbest Pharmaceuticals, Inc. (557054835)
Establishment
NameAddressID/FEIOperations
Pharbest Pharmaceuticals, Inc.557054835manufacture, label, pack

 
Pharbest Pharmaceuticals, Inc.

See Also

Further information

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

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