Label: COLD AND COUGH DM- brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl solution
- NDC Code(s): 56062-987-26
- Packager: Publix Super Markets 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 May 25, 2022
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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
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Warnings
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
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
When using this product
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- do not use more than directed
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- may cause marked drowsiness
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- avoid alcoholic beverages
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- alcohol, sedatives and tranquilizers may increase drowsiness
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- be careful when driving a motor vehicle or operating machinery
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- excitability may occur, especially in children
- Directions
- Other information
- Inactive ingredients
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Principal Display Panel
P
FOR AGES 6 YRS. & OVER
CHILDREN’S
cold & cough DM
ANTIHISTAMINE, BROMPHENIRAMINE MALEATE
COUGH SUPPRESSANT, DEXTROMETHORPHAN HBr
NASAL DECONGESTANT, PHENYLEPHRINE HCl
Relief of:
• Stuffy Nose
• Runny Nose
• Sneezing
• Itchy, Watery Eyes
• Cough
ALCOHOL-FREE
GRAPE FLAVORED
Compare to Children’s Dimetapp® Cold & Cough active ingredients
4 FL OZ (118 mL)
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INGREDIENTS AND APPEARANCE
COLD AND COUGH DM
brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:56062-987 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:56062-987-26 1 in 1 CARTON 02/10/2014 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 02/10/2014 Labeler - Publix Super Markets Inc (006922009)