OTC Medication Information: Pharbetol Regular Strength

PHARBETOL REGULAR STRENGTH- acetaminophen tablet
A-S Medication Solutions

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 tablet)

Acetaminophen 325mg

Purpose

Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
  • the common cold
  • headache
  • backache
  • minor pain of arthritis
  • toothache
  • muscular aches
  • premenstrual and menstrual cramps
  • temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children.

Severe liver damage may occur if

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours, which is the maximum daily amount
  • taken with other drugs containing acetaminophen
  • adult has 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 in adults
  • pain gets worse or lasts more than 5 days in children under 12 years
  • 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 the reach of children.

Overdose warning:

In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

  • do not take more than directed (see overdose warning).

adults and children 12 years and over
  • take 2 tablets, every 4 to 6 hours while symptoms last
  • do not take more than 10 tablets in 24 hours, unless directe by a doctor
  • do not use for more than 10 days unless directed by a doctor
children 6 to 11 years
  • take 1 tablet every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours
  • do not use for more than 5 days unless directed by a doctor
children under 6 years ask a doctor

Other information

  • Tamper Evident: do not use if imprinted safety seal under cap is broken or missing
  • store between 20-25°C (68-77°F)

Inactive ingredients

povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions?

Adverse drug event call: (866) 562-2756 Mon-Fri 8 AM to 4 PM

HOW SUPPLIED

Product: 50090-0267

NDC: 50090-0267-1 15 TABLET in a BOTTLE

NDC: 50090-0267-2 100 TABLET in a BOTTLE

NDC: 50090-0267-3 30 TABLET in a BOTTLE

NDC: 50090-0267-4 20 TABLET in a BOTTLE

Acetaminophen

Label ImageLabel Image
PHARBETOL REGULAR STRENGTH
acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-0267(NDC:16103-353)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE, UNSPECIFIED
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A CORN
STEARIC ACID
Product Characteristics
Color white Score no score
Shape ROUND Size 10mm
Flavor Imprint Code PH020
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-0267-1 15 TABLET in 1 BOTTLE None
2 NDC:50090-0267-2 100 TABLET in 1 BOTTLE None
3 NDC:50090-0267-3 30 TABLET in 1 BOTTLE None
4 NDC:50090-0267-4 20 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 01/09/2007
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-0267), REPACK (50090-0267)

Revised: 04/2021 A-S Medication Solutions

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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