Label: ACETAMINOPHEN ORAL SOLUTION solution
- NDC Code(s): 55154-3360-5
- Packager: Cardinal Health
- This is a repackaged label.
- Source NDC Code(s): 0904-6820
- 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.
Updated October 23, 2020
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- Active ingredient
- Indications and Usage
- Instructions For Use
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
- adults take more than 6 doses 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
- If a skin reaction occurs, stop use and seek medical help right away
- Do Not Use
- Other Safety Information
- Ask Doctor
- Stop Use
Keep Out of Reach of Children
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 Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- Inactive Ingredients
- Package/Label Principal Display Panel
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN ORAL SOLUTION
acetaminophen oral solution solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55154-3360(NDC:0904-6820) 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 GLYCERIN (UNII: PDC6A3C0OX) SODIUM BENZOATE (UNII: OJ245FE5EU) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) SORBITOL (UNII: 506T60A25R) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) METHYLCELLULOSE (15 MPA.S) (UNII: NPU9M2E6L8) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) Product Characteristics Color white (white to light pink) Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55154-3360-5 5 in 1 BAG 04/08/2019 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 not final part343 04/08/2019 Labeler - Cardinal Health (603638201)