Label: ACETAMINOPHEN solution
- NDC Code(s): 55154-9449-5
- Packager: Cardinal Health 107, LLC
- This is a repackaged label.
- Source NDC Code(s): 0121-1971
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated January 9, 2024
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- Official Label (Printer Friendly)
- Active ingredient (in each 5 mL teaspoonful)
- Purpose
- Uses
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if:
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- adult takes more than 6 doses in 24 hours, which is the maximum daily amount
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- child takes more than 5 doses in 24 hours
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- taken with other drugs containing acetaminophen
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- adult has 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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- skin reddening
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- blisters
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- 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
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- with any other drug containing acetaminophen (prescription or nonprescription).
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- if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- for more than 10 days for pain unless directed by a doctor
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- for more than 3 days for fever unless directed by a doctor
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- if you are allergic to acetaminophen or any of the inactive ingredients of this product
Stop use and ask a doctor if
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- symptoms do not improve
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- new symptoms occur
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- 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
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- 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 periodchildren 6 to under 12 years of age
10.15 mL (325 mg) every 4 hours
not to exceed 5 doses in a 24-hour periodchildren 4 to under 6 years of age
7.5 mL (240 mg) every 4 hours
not to exceed 5 doses in a 24-hour periodchildren 2 to under 4 years of age
5 mL (160 mg) every 4 hours
not to exceed 5 doses in a 24-hour periodchildren under 2 years of age
consult a doctor
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Other information
■ Each 5 mL contains: sodium 2 mg
■ 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:
650mg/20.3 mL unit dose cup
Overbagged with 5 x 20.3 mL unit dose cups per bag, NDC 55154-9449-5
- Inactive ingredients:
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55154-9449(NDC:0121-1971) 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:55154-9449-5 5 in 1 BAG 08/01/2007 1 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 08/01/2007 Labeler - Cardinal Health 107, LLC (118546603)
