Label: ACETAMINOPHEN solution
- NDC Code(s): 60687-740-24, 60687-740-37, 60687-740-53
- Packager: American Health Packaging
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated October 21, 2024
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- Official Label (Printer Friendly)
- Purpose
- Active ingredient (in each 20.3 mL cup)
- Uses
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Warnings
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
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 under 12 years of age
consult a doctor
- Other information
- Inactive ingredients:
- Questions or comments?
- SPL UNCLASSIFIED SECTION
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Package/Label Principal Display Panel – Tray Label
Case NDC 60687-740-37/Cup NDC 60687-740-24
ACETAMINOPHEN
ORAL SOLUTION USP650 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
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Package/Label Principal Display Panel – Cup Label – 650 mg/20.3 mL
NDC 60687- 740-24
ACETAMINOPHEN
ORAL SOLUTION USP
Pain Reliever/Fever Reducer
650 mg / 20.3 mLALCOHOL FREE
Delivers 20.3 mLProtect from light.
See package Drug Facts insert for full
prescribing information and storage.For Institutional Use Only.
American Health Packaging
Columbus, OH 43217F0657C210323
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60687-740 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg in 20.3 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:60687-740-37 10 in 1 CASE 07/27/2023 1 NDC:60687-740-53 10 in 1 TRAY 1 NDC:60687-740-24 20.3 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 Drug M013 07/27/2023 Labeler - American Health Packaging (929561009)