Label: ACETAMINOPHEN solution
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NDC Code(s):
0904-7319-41,
0904-7319-70,
0904-7320-02,
0904-7320-71, view more0904-7321-03, 0904-7321-76
- Packager: Major Pharmaceuticals
- This is a repackaged label.
- Source NDC Code(s): 0121-0657
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 9, 2025
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient(s)
- Purpose
- Uses
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if:
- adult takes more than 6 doses in 24 hours, which is the maximum daily amount
- child takes more than 5 doses in 24 hours
- 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
Ask a doctor before use if the user has liver disease
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
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.
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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 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
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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:
NDC 0904-7319-41: 5 mL unit dose cup, in a tray of ten cups.
NDC 0904-7320-02: 10.15 mL unit dose cup, in a tray of ten cups.
NDC 0904-7321-03: 20.3 mL unit dose cup, in a tray of ten cups.
- Inactive ingredients
- Questions or comments?
- Distributed by:
- PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup
- PRINCIPAL DISPLAY PANEL - 10.15 mL Unit Dose Cup
- PRINCIPAL DISPLAY PANEL - 20.3 mL Unit Dose Cup
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-7319(NDC:0121-0657) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg in 5 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 (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SUCROSE (UNII: C151H8M554) Product Characteristics Color red ((clear, red liquid)) Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0904-7319-70 10 in 1 CASE 06/05/2023 1 10 in 1 TRAY 1 NDC:0904-7319-41 5 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 06/05/2023 ACETAMINOPHEN
acetaminophen solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-7320 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 (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:0904-7320-71 10 in 1 CASE 06/05/2023 1 10 in 1 TRAY 1 NDC:0904-7320-02 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 Drug M013 06/05/2023 ACETAMINOPHEN
acetaminophen solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-7321 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 (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:0904-7321-76 10 in 1 CASE 06/05/2023 1 10 in 1 TRAY 1 NDC:0904-7321-03 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 06/05/2023 Labeler - Major Pharmaceuticals (191427277)
