OTC Medication Information: Pharbetol

PHARBETOL- acetaminophen tablet
Proficient Rx LP

Active ingredient (in each tablet)

Acetaminophen 500mg

Purpose

Pain reliever/fever reducer

Uses

Temporarily 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 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 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 ingredients

Povidone, Pregelatinized corn starch, sodium starch glycolate, stearic acid.

Questions?

Adverse drug event call: (866) 562-2756

Repackaged by:

Proficient Rx LP

Thousand Oaks, CA 91320

71205-990-00
(click image for full-size original)

NDC 71205-990-00

Manufactured in the USA

Extra Strength *Compare to the active ingredient in Extra Strength Tylenol Caplet

Do not use any other product containing acetaminophen

Acetaminophen 500mg

Pain Reliever Fever Reducer

100 Tablets

PHARBETOL
acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71205-990(NDC:16103-376)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE K30
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
Product Characteristics
Color white Score no score
Shape ROUND Size 12mm
Flavor Imprint Code PH044
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71205-990-50 50 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:71205-990-00 100 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:71205-990-55 500 TABLET in 1 BOTTLE, PLASTIC None
4 NDC:71205-990-11 1000 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M013 01/10/2006
Labeler — Proficient Rx LP (079196022)
Establishment
Name Address ID/FEI Operations
Proficient Rx LP 079196022 REPACK (71205-990), RELABEL (71205-990)

Revised: 02/2024 Proficient Rx LP

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.

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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