OTC Medication Information: Acetaminophen

ACETAMINOPHEN- acetaminophen tablet
Aphena Pharma Solutions — Tennessee, LLC

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 325 mg

Purpose

Pain Reliever / Fever Reducer

Uses

temporarily reduces fever and relieves minor aches and pains caused by

  • common cold
  • headache
  • toothache
  • backache
  • muscular aches
  • minor pain of arthritis
  • premenstrual and menstrual cramps

Warnings

Liver warning: this product contains acetaminophen. Severe liver damage may occur if

  • adult takes more than 12 tablets in 24 hours, which is the maximum daily amount
  • child takes more than 5 tablets 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

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.

Ask a doctor before use if the user has liver disease

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

Stop use and ask a doctor if

  • adult’s pain gets worse or lasts more than 10 days
  • child’s pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • any new symptoms appear

If pregnant or breast-feeding, ask a health professional before use.

Overdose warning:Taking more than the recommended dose may cause liver damage. In case of overdose contact Poisom Control Center right away. Quick medical attention is critical for adults as well as children even if you do not notice any signs of symptoms.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

Directions

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

Other Information

store at 15-30 °C (59-86 °F)

Inactive Ingredients

polyvinylpyrrolidone, pregelatinized corn starch, sodium starch glycolate, stearic acid

Questions or Comments

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

call 804-270-4498, 8.30 am-4.30 pm ET, Monday — Friday

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma — TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count325 mg
10071610-238-65

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:
Aphena Pharma Solutions -- TN
Cookeville, TN 38506
20190226JH

PRINCIPAL DISPLAY PANEL — 325 mg

NDC 71610-238 — Acetaminophen, USP 325 mg Tablets — Rx Only

Bottle Label 325 mg
(click image for full-size original)

ACETAMINOPHEN
acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71610-238(NDC:54738-548)
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
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
Product Characteristics
Color white Score no score
Shape ROUND Size 10mm
Flavor Imprint Code AP;012
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71610-238-65 100 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 05/01/2015
Labeler — Aphena Pharma Solutions — Tennessee, LLC (128385585)
Establishment
Name Address ID/FEI Operations
Aphena Pharma Solutions — Tennessee, LLC 128385585 REPACK (71610-238)

Revised: 02/2019 Aphena Pharma Solutions — Tennessee, LLC

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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