Label: SUPRESS A- dexbromopheniramine maleate, dextromethorphan hbr, phenylephrine hcl syrup
- NDC Code(s): 52083-057-01
- Packager: Kramer Novis
- 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 December 22, 2017
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each 1 mL)
- Purpose
-
Uses
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- sneezing
- itchy nose or throat
- runny nose
- itchy, watery eyes
- nasal congestion
- temporarily controls cough due to minor throat and bronchial irritation associated with inhaled irritants
- temporarily restores freer breathing through nose
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Warnings
Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
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Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis, or emphysema
- Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers
- do not exceed recommended dosage
- excitability may occur, especially in children
- may cause marked drowsiness
- sedative and tranquilizers may increase drowsiness effect
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STOP USE
Stop use and ask a doctor if
- nervousness dizziness, or sleeplessness occur
- new symptoms occur
- symptoms do not improve within 7 days or are accompanied by fever
- cough lasts more than 7 days, comes back or is accompanied by fever, rash, or persistent headache
These could be signs of a serious condition.
- PREGNANCY OR BREAST FEEDING
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SUPRESS A
dexbromopheniramine maleate, dextromethorphan hbr, phenylephrine hcl syrupProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52083-057 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP) DEXBROMPHENIRAMINE MALEATE 1 mg in 1 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 1 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 1 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) POLYSORBATE 20 (UNII: 7T1F30V5YH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color Score Shape Size Flavor GRAPE (GRAPE) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52083-057-01 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/01/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 08/01/2012 Labeler - Kramer Novis (090158395) Registrant - KRAMER NOVIS (090158395)
