Label: ACETAMINOPHEN solution
- Category: HUMAN OTC DRUG LABEL
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.
Updated December 13, 2019
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- Active ingredient (in each 10.15 mL)
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
■ more than 4000 mg in 24 hours
■ with other drugs containing acetaminophen
■ 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.
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.
■ if you are allergic to acetaminophen or any of the inactive ingredients in this product
Stop use and ask a doctor if
■ pain gets worse or lasts more than 10 days
■ fever gets worse or lasts more than 3 days
■ new symptoms occur
■ redness or swelling is present
These could be signs of a serious condition.
■ do not take more than directed (see overdose warning)
■ do not take more than 8 doses in any 24-hour period
■ dose as follows or as directed by doctor
■ take only with dosing cup provided
■ adults and children 12 years of age and older: 10.15 mL (325 mg) every 3 - 4 hours
■ children under 12 years of age: ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
- How Supplied
- Principal Display Panel - 10.15 mL Lidding Label
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66689-055 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 BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM CITRATE (UNII: 1Q73Q2JULR) SACCHARIN SODIUM (UNII: SB8ZUX40TY) 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:66689-055-99 10 in 1 CASE 11/22/2019 1 10 in 1 TRAY 1 NDC:66689-055-01 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 11/22/2019 Labeler - VistaPharm, Inc. (116743084)