Label: ACETAMINOPHEN solution
- NDC Code(s): 60687-751-42, 60687-751-48, 60687-751-56
- Packager: American Health Packaging
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated July 21, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Purpose
- Active ingredient (in each 10.15 mL cup)
- Uses
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Warnings
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
- adult takes more than 10 unit dose cups in 24 hours, which is the maximum daily amount
- child takes more than 5 unit dose cups in 24 hours, which is the maximum daily amount
- 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
Stop use and ask a doctor if
- symptoms do not improve
- new symptoms occur
- pain or fever persists or gets worse
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.
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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 under 6 years of age
consult a doctor
- Other information
- Inactive ingredients:
- Questions or comments?
- SPL UNCLASSIFIED SECTION
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Principal Display Panel – Tray Label
Case NDC 60687-751-56/Cup NDC 60687-751-42
ACETAMINOPHEN
ORAL SOLUTION USP325 mg/10.15 mL
ALCOHOL FREE
Each 10.15 mL contains:
Acetaminophen 325 mgUSUAL DOSAGE:See attached Drug Facts
Store at 20° to 25°C (68° to 77°F)
[See USP Controlled Room Temperature].For Institutional Use Only.
T0657C110323 R03/23
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Principal Display Panel – Cup – 325 mg / 10.15 mL
NDC 60687- 751-42
ACETAMINOPHEN
ORAL SOLUTION USPPain Reliever/Fever Reducer
325 mg/10.15 mL
ALCOHOL FREE
Delivers 10.15 mL
Protect from light.
See packaging Drug Facts insert for full
prescribing information and storage.For Institutional Use Only.
American Health Packaging
Columbus, OH 43217F0657C110323
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60687-751 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg in 10.15 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SUCROSE (UNII: C151H8M554) Product Characteristics Color red Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60687-751-56 10 in 1 CASE 07/21/2023 1 NDC:60687-751-48 10 in 1 TRAY 1 NDC:60687-751-42 10.15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 07/21/2023 Labeler - American Health Packaging (929561009)
