OTC Medication Information: ACETAMINOPHEN

ACETAMINOPHEN- acetaminophen tablet
Preferred Pharmaceuticals, Inc.

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 500 mg

Purposes

Pain reliever/fever reducer

Uses

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

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 tablets (3,000 mg) in 24 hours. Severe liver damage may occur if you take

more than 4,000 mg of acetaminophen in 24 hours
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 non prescription). 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 (1-800-222-1222). 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 (see overdose warning)

Adults and children 12 years and over:

take 2 tablets every 6 hours while symptoms last
do not take more than 6 tablets in 24 hours unless directed by a doctor
do not take for more than 10 days unless directed by a doctor.

Children under 12 years: ask a doctor.

Other information

Do not use if imprinted safety seal under cap is broken or missing.
Store at room temperature

Inactive ingredients

Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid

Questions?

If you have any questions or comments, or to report an adverse event, please contact 1 800-medline.

Principal Display Panel

ONDRA
PHARMACEUTICALS
See New Warnings Information and Directions
Extra Strength
Acetaminophen 500 mg
PAIN RELIEVER
FEVER REDUCER
CONTAINS NO ASPIRIN

Repackaged By: Preferred Pharmaceuticals Inc.
Compare to the Active Ingredient in Extra Strength Tylenol®
This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark of Extra Strength Tylenol®

Extra Strength Acetaminophen 500mg
(click image for full-size original)

ACETAMINOPHEN acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-9399(NDC:51645-602)
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, UNSPECIFIED
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
Product Characteristics
Color white Score 2 pieces
Shape ROUND (round flat faced beveled edge) Size 12mm
Flavor Imprint Code GPI;A5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-9399-2 20 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:68788-9399-3 30 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:68788-9399-4 45 TABLET in 1 BOTTLE, PLASTIC None
4 NDC:68788-9399-5 50 TABLET in 1 BOTTLE, PLASTIC None
5 NDC:68788-9399-1 100 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 06/16/2014
Labeler — Preferred Pharmaceuticals, Inc. (791119022)
Registrant — Preferred Pharmaceuticals, Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals, Inc. 791119022 REPACK (68788-9399)

Revised: 08/2017 Preferred Pharmaceuticals, Inc.

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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