Label: PHENAGIL- chlorpheniramine maleate, dextromethorphan hbr and phenylephrine hcl tablet
-
Contains inactivated NDC Code(s)
NDC Code(s): 66576-337-01 - Packager: Syntho Pharmaceuticals, Inc.
- 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.
Drug Label Information
Updated June 13, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Purposes
-
Uses
Temporarily relieves:
• cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants.
• nasal congestion due to the common cold, hay fever or other upper respiratory allergies.
• temporarily relieves these symptoms due to hay fever (allergic rhinitis):
• runny nose.
• sneezing.
• itchy, watery eyes.
• itching of the nose or throat.
• temporarily restores freer breathing through the nose.
-
Warnings
Do not use
• to sedate a child or to make a child sleepy.
• 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. -
Ask a doctor before use if you have
• heart disease.
• high blood pressure.
• thyroid disease.
• diabetes.
• trouble urinating due to an enlarged prostate gland.
• glaucoma.
• cough that occurs with too much phlegm (mucus).
• a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema. - Ask a doctor or pharmacist before use if you are
- When using this product
- Stop use and ask a doctor if
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PHENAGIL
chlorpheniramine maleate, dextromethorphan hbr and phenylephrine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66576-337 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 3.5 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 29 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 10 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Product Characteristics Color white Score no score Shape ROUND Size 3mm Flavor Imprint Code 323;Gil Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66576-337-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/26/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/26/2022 Labeler - Syntho Pharmaceuticals, Inc. (088797407)