OTC Medication Information: Acetaminophen

ACETAMINOPHEN- acetaminophen solution
American Health Packaging

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 10.15 mL cup) Acetaminophen, USP 325 mg

(in each 20.30 mL cup) Acetaminophen, USP 650 mg

Purpose

Pain reliever/fever reducer

Uses

  • temporarily relieves 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 (10.15 mL unit dose cups)

Liver Warning: This product contains acetaminophen. The maximum daily dose of this product is 10 unit dose cups (3,250 mg) in 24 hours for adults or 5 unit dose cups (1,625 mg) in 24 hours for children, which is the maximum daily amount for this product. Severe liver damage may occur if

  • adult takes more than 10 unit dose cups (101.50 mL) in 24 hours
  • child takes more than 5 unit dose cups (50.75 mL) 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.

Warnings (20.30 mL unit dose cups)

Liver Warning: This product contains acetaminophen. The maximum daily dose of this product is 5 unit dose cups (3,250 mg) in 24 hours for adults, which is the maximum daily amount for this product. Severe liver damage may occur if

  • adult takes more than 5 unit dose cups (101.50 mL) in 24 hours
  • 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 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

  • pain gets worse or last for more than 10 days in adults
  • pain gets worse or last for more than 5 days in children under 12 years
  • fever gets worse or lasts for 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: In 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 (10.15 mL unit dose cups)

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

adults and children 12 years and over

  • take 2 unit dose cups (20.30 mL) every 4 to 6 hours while symptoms last
  • do not take more than 10 unit dose cups (101.50 mL0 in 24 hours, unless directed by a doctor
  • do not use for mor than 10 days unless directed by a doctor

children 6 years to under 12 years

  • take 1 unit dose cup (10.15 mL) every 4 to 6 hours while symptoms last
  • do not take more than 5 unit does cups (50.75 mL) in 24 hours
  • do not use for more than 5 days unless directed by a doctor

children under 6 years

ask a doctor

Directions (20.30 mL unit dose cups)

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

adults and children 12 years and over

  • take 1 unit dose cups (20.30 mL) every 4 to 6 hours while symptoms last
  • do not take more than 5 unit dose cups (101.50 mL0 in 24 hours, unless directed by a doctor
  • do not use for mor than 10 days unless directed by a doctor

children 6 years to under 12 years

ask a doctor

Other Information

  • each 10.15 mL contains: sodium 33.5 mg
  • each 22.30 mL contains: sodium 67 mg
  • Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F)
  • Protect from light
  • DO NOT USE IF SEAL IS BROKEN
  • This drug product is supplied in 10.15 mL unit dose cups as:100 cups (10 x 10) NDC 60687-571-56
  • This drug product is supplied in 20.30 mL unit dose cups as:100 cups (10 x 10) NDC 60687-571-37

Inactive Ingredients

anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, artificial cherry flavor, glycerin, methylparaben, polyethylene glycol, propylparaben, purified water, sodium citrate, sodium saccharin

Packaging Information

American Health Packaging unit dose cups (see Other Information section) contain drug product from Woodfield Pharmaceutical LLC as follows:
(325 mg per 10.15 mL / 100UD) NDC 60687-571-56 packaged from NDC 72207-114
(650 mg per 20.30 mL / 100UD) NDC 60687-571-37 packaged from NDC 72207-114

Distributed by:
American Health Packaging
Columbus, Ohio 43217

8457156/0621F 8457137/0621F

Package/Label Principal Display Panel — Tray

325mg per 10.15mL Acetaminophen Oral Solution Label
(click image for full-size original)

Acetaminophen
Oral Solution, USP
Pain Reliever/Fever Reducer

325 mg/10.15 mL

Artificial Cherry Flavor

FOR INSTITUTIONAL USE ONLY

Store at 20°C to 25°C (68°F to 77°F),
excursions permitted between
15°C and 30°C (between 59°F and 86°F). Protect from light.

8457156/0621F

650 mg per 20.30 mL Acetaminophen Oral Solution Label
(click image for full-size original)

Acetaminophen
Oral Solution, USP
Pain Reliever/Fever Reducer

650 mg/20.30 mL

Artificial Cherry Flavor

FOR INSTITUTIONAL USE ONLY

Store at 20°C to 25°C (68°F to 77°F),
excursions permitted between
15°C and 30°C (between 59°F and 86°F). Protect from light.

8457137/0621F

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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.

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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