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
- 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 June 13, 2023
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
- Use(s)
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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.
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
- do not take more than directed (see overdose warning)
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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 not final part343 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 not final part343 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 not final part343 06/05/2023 Labeler - Major Pharmaceuticals (191427277)
