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Drug Facts
Acetaminophen Solution
FDA Label NDC 0121-0657
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pai Holdings, Llc Dba Pai Pharma for the product Acetaminophen (NDC 0121-0657). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient (in each 5 ml teaspoonful), purpose, uses, liver warning, allergy alert, sore throat warning, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each 5 Ml Teaspoonful)
Acetaminophen 160 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
Liver Warning
This product contains acetaminophen. Severe liver damage may occur if you take:
- adult takes more than 6 doses in 24 hours, which is the maximum daily amount
- child takes more than 5 doses in 24 hours
- with other drugs containing acetaminophen
- 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
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
- 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 6 to under 12 years of age | 10.15 mL (325 mg) every 4 hours
not to exceed 5 doses in a 24-hour period |
| children 4 to under 6 years of age | 7.5 mL (240 mg) every 4 hours
not to exceed 5 doses in a 24-hour period |
| children 2 to under 4 years of age | 5 mL (160 mg) every 4 hours
not to exceed 5 doses in a 24-hour period |
| children under 2 years of age | consult a doctor |
Other Information
■ sodium content: 2 mg/5 mL
■ store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature]
■ keep tightly closed ■ protect from light
■ a red, cherry flavored solution supplied in the following oral dosage forms:
NDC 0121-0657-05: 5 mL unit dose cup
NDC 0121-0657-00: Case contains 100 unit dose cups of 5 mL (0121-0657-05) packaged in 10 trays of 10 unit dose cups each.
NDC 0121-1314-11: 10.15 mL unit dose cup
NDC 0121-1314-00: Case contains 100 unit dose cups of 10.15 mL (0121-1314-11) packaged in 10 trays of 10 unit dose cups each.
NDC 0121-1971-21: 20.3 mL unit dose cup
NDC 0121-1971-00: Case contains 100 unit dose cups of 20.3 mL (0121-1971-21) packaged in 10 trays of 10 unit dose cups each.
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.
Manufactured By:
Pharmaceutical Associates, Inc.
Greenville, SC 29605
www.paipharma.com
R01/17
Principal Display Panel - 20 Ml Cup
Delivers 20.3 mL
NDC 0121-1971-21
A CETAMINOPHEN
O RAL S OLUTION USP
650 mg/20.3 mL
ALCOHOL FREE
FOR INSTITUTIONAL USE ONLY
PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605
SEE INSERT
F06572102
20 mL Unit Dose Cup Label (Acetaminophen 01) 
Principal Display Panel - 10 Ml Cup
Delivers 10.15 mL
NDC 0121-1314-11
A CETAMINOPHEN
O RAL S OLUTION USP
325 mg/10.15 mL
ALCOHOL FREE
FOR INSTITUTIONAL USE ONLY
PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605
SEE INSERT
F06571102
10 mL Unit Dose Cup Label (Acetaminophen 02) 
Principal Display Panel - 5 Ml Cup
Delivers 5 mL
NDC 0121-0657-05
A CETAMINOPHEN
O RAL S OLUTION USP
160 mg/5 mL
ALCOHOL FREE
FOR INSTITUTIONAL USE ONLY
PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605
SEE INSERT
A06570500
5 mL Unit Dose Cup Label (Acetaminophen 03)
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