Label: ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHRINE HYDROCHLORIDE capsule, liquid filled
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 May 30, 2017
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- Active ingredient
• temporarily relieves these symptoms due to cold and flu:
itching of the nose, throat or watery eyes due to hay fever
sinus congestion and pressure
minor aches and pains
• helps clear nasal passages and shrinks swollen membranes
• temporarily reduces fever
- Liver warning
- Allergy alert
- Sore throat warning
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 now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
• if you ever had an allergic reaction to this product or any of its ingredients.
• in children 12 years of age.
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
- When using this product
Stop use and ask a doctor if
• pain, cough, or nasal congestion gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• cough comes back or occurs with rash or head ache that lasts for 1 week, these could be the signs of serious condition
• nervousness, dizziness, or sleeplessness occurs
- If pregnant or breast-feeding
- Keep out of the reach of children
- Other information
- Inactive ingredients
- Questions or comments?
- Daytime Softgels
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHRINE HYDROCHLORIDE
acetaminophen dextromethorphan hydrobromide phenylephrine hydrochloride capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62207-912 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN (UNII: 2G86QN327L) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POVIDONE (UNII: FZ989GH94E) GLYCERIN (UNII: PDC6A3C0OX) SODIUM HYDROXIDE (UNII: 55X04QC32I) SORBITOL (UNII: 506T60A25R) Product Characteristics Color blue Score no score Shape OVAL Size 20mm Flavor Imprint Code G02 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62207-912-69 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 07/07/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/07/2017 Labeler - Granules India Limited (915000087)