FDA Label for Acetaminophen

Purpose

Pain reliever/fever reducer

Active Ingredient(In Each 20.3 Ml Cup)

Acetaminophen     650 mg

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

Liver Warning:

This product contains acetaminophen. Severe liver damage may occur if:

• adult takes more than 5 unit dose cups 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.

Sore Throat Warning:

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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.
• for more than 10 days for pain unless directed by a doctor
• for more than 3 days for fever unless directed by a doctor
• if you are allergic to acetaminophen or any of the inactive ingredients of this product

Otc - Ask Doctor/Pharmacist

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

Stop Use And Ask A Doctor If

• symptoms do not improve
• new symptoms occur
• pain or fever persists or gets worse

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdose Warning:

Taking more than the recommended dose (overdose) may cause liver damage. 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 children even if you do not notice any signs or symptoms.

Directions

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

age	dose
adults and children 12 years of age and over	20.3 mL (650 mg) every 4 to 6 hours not to exceed 6 doses in a 24-hour period
children under 12 years of age	consult a doctor

Other Information

• Each 20.3 mL contains: sodium 8 mg
• store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]
• protect from light

  a red, cherry flavored solution supplied in the following oral dosage forms:
  20.3 mL unit dose cups: 100 cups (10 x 10) NDC 60687-740-37

Inactive Ingredients:

Citric acid, FD&C Red No. 40, flavoring, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol and sucrose.

Questions Or Comments?

Call 1-800-845-8210. You may also report serious side effects to this phone number.

Other

DO NOT USE IF SEAL IS BROKEN.

Distributed by:
American Health Packaging
Columbus, OH 43217

R03/23

Package/Label Principal Display Panel – Tray Label

Tray Label - Label

Case NDC 60687-740-37/Cup NDC 60687-740-24

ACETAMINOPHEN
ORAL SOLUTION USP

650 mg/20.3 mL

ALCOHOL FREE

Each 20.3 mL contains:

Acetaminophen       650 mg

USUAL DOSAGE:See attached Drug Facts

Store at 20° to 25°C (68° to 77°F)
[See USP Controlled Room Temperature].

For Institutional Use Only.

T0657C210323       R03/23

Package/Label Principal Display Panel – Cup Label – 650 Mg/20.3 Ml

650 mg/20.3 mL Acetaminophen Oral Solution Cup Label - Cup

NDC 60687- 740-24

ACETAMINOPHEN
ORAL SOLUTION USP
Pain Reliever/Fever Reducer
650 mg / 20.3 mL

ALCOHOL FREE
Delivers 20.3 mL

Protect from light.

See package Drug Facts insert for full
prescribing information and storage.

For Institutional Use Only.

American Health Packaging
Columbus, OH 43217

F0657C210323