ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE PHENYLEPHRINE HCL capsule, liquid filled
Acetaminophen Dextromethorphan HBr Doxylamine succinate Phenylephrine HCl by
Drug Labeling and Warnings
Acetaminophen Dextromethorphan HBr Doxylamine succinate Phenylephrine HCl by is a Otc medication manufactured, distributed, or labeled by CVS PHARMACY, INC. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- Active ingredients
- Purposes
-
Uses
temporarily relieves these symptoms due to cold and flu:
- sneezing
- itching of the nose, throat or watery eyes due to hay fever
- cough
- nasal congestion
- sinus congestion and pressure
- sore throat
- head ache
- 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 have
- 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
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- Active ingredients
- Purposes
-
Uses
temporarily relieves these symptoms due to cold and flu:
- sneezing
- itching of the nose, throat or watery eyes due to hay fever
- cough
- nasal congestion
- sinus congestion and pressure
- sore throat
- headache
- minor aches and pains
- runny nose
helps clear nasal passages and shrinks swollen membranes
temporarily reduces fever - Liver warning
- Allergy alert
- Sore throat warning
- Do not use to sedate children.
-
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
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- cough with excess phlegm (mucus)
- a breathing problem such as emphysema or chronic bronchitis
- difficulty in urination due to enlargement of the prostate gland
- persistent or chronic cough occurs with smoking, asthma, or emphysema
- 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
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE PHENYLEPHRINE HCL
acetaminophen dextromethorphan hbr doxylamine succinate phenylephrine hcl capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 69842-303 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GELATIN (UNII: 2G86QN327L) SORBITAN (UNII: 6O92ICV9RU) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) FD&C RED NO. 40 (UNII: WZB9127XOA) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POVIDONE K30 (UNII: U725QWY32X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Product Characteristics Color green, orange (534 (Daytime)) Score no score Shape OVAL (Orange (Daytime) Green (Nighttime)) Size 20mm Flavor Imprint Code 534 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 69842-303-02 20 in 1 BLISTER PACK; Type 0: Not a Combination Product 11/30/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 11/30/2017 Labeler - CVS PHARMACY, INC (062312574)
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