Label: ACETAMINOPHEN ORAL SOLUTION solution
- NDC Code(s): 55154-8088-5
- Packager: Cardinal Health
- This is a repackaged label.
- Source NDC Code(s): 0904-6738
- 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 June 8, 2020
If you are a consumer or patient please visit this version.
- Active Ingredient
- Acetaminophen 160 mg / 5 mL Unit Dose Cup
- Keep Out of Reach of Children
Warnings and Precautions
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 other inactive ingredients in this product
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.
- Do Not Use
- Ask Doctor
- Ask Doctor/Pharmacist
Stop use and ask a doctor if:
- pain gets worse or lasts more than 10 days - new symptoms occur
- fever gets worse or lasts more than 3 days - redness or swelling is present
These could be signs of a serious condition
Inactive ingredients cherry flavor, citric acid, glycerin, methylcellulose, microcrystalline cellulose, propyl paraben, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xantham gum
- store at 20°-25°C (68°-77°F). Avoid excessive heat 40°C (104°F)
- protect from excessive moisture - do not use if lid seal is open or damaged
- sugar free, dye free, alcohol free - see bottom of cup for lot number and expiration date
Dublin, OH 43017
- Principal Display Panel
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN ORAL SOLUTION
acetaminophen oral solution solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55154-8088(NDC:0904-6738) 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 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:55154-8088-5 5 in 1 BAG 04/08/2019 1 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 04/08/2019 Labeler - Cardinal Health (603638201)