Label: COLD AND COUGH- brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl solution
- NDC Code(s): 37808-987-26
- Packager: H E B
- 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 April 19, 2018
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- Official Label (Printer Friendly)
- Active ingredients (in each 10 mL)
- Purposes
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Uses
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- temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies
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- temporarily relieves these symptoms due to hay fever (allergic rhinitis):
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- runny nose
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- sneezing
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- itchy, watery eyes
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- itching of the nose or throat
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- temporarily restores freer breathing through the nose
- Warnings
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Do not use
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- 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.
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- to make a child sleepy
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Ask a doctor before use if you have
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- heart disease
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- high blood pressure
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- thyroid disease
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- diabetes
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- trouble urinating due to an enlarged prostate gland
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- glaucoma
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- cough that occurs with too much phlegm (mucus)
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- a breathing problem such as emphysema or chronic bronchitis
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- cough that lasts or is chronic such as 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
- If pregnant or breast-feeding,
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
Compare to Children’s Dimetapp® Cold & Cough active ingredients
children’s Cold & Cough
Brompheniramine Maleate/Antihistamine
Dextromethorphan HBr/Cough Suppressant
Phenylephrine HCl/Nasal Decongestant
Multi – Symptom
For Ages 6 Yrs. & Over
Relief of:
Nasal Congestion
Runny Nose
Sneezing
Itchy, Watery Eyes
Coughing
Grape Flavor
Alcohol Free
4 FL OZ (118 mL)
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INGREDIENTS AND APPEARANCE
COLD AND COUGH
brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-987 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE 2 mg in 10 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 10 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 10 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) Product Characteristics Color PURPLE (Clear bluish-red) Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37808-987-26 1 in 1 CARTON 09/21/2006 1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 09/21/2006 Labeler - H E B (007924756)