Label: BRONCOMAR- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 53113-215-06 - Packager: Gadal Laboratories 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 23, 2014
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ACTIVE INGREDIENT
Acvtive ingredients: (in 10 ml) Purpose
Acetaminophen 200 mg ............................. Analgesic
Dextromethorphan HBr 13.33 mg ................... Cough Suppressant
Guaifenesin 200 mg ................................... Expectorant
Phenylephrine HCl 5 mg ............................. Decongestant
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
Do not exceed recommended dosage
Liver warning: This product contains Acetaminophen. Sever liver damage may occur if
- Adult takes more than 6 doses in 24 hours, which is the maximum daily amount
- Child takes more than 5 doses in 24 hours
- Taken with other drugs containing Acetaminophen
- Adult has 3 or more alcoholic drinks everyday while using this product
- Do not give to children under 3 years of age or use for more than 10 days unless directed by a physician
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DO NOT USE
Do not use
- If you are now taking a prescription monoamine oxidase inhibitor (MAOI)( certain drugs for depression , psychiatric conditions, or Parkinson’s disease) or for 2 weeks after stopping the MAOI drug.
- if you do not know if your prescription drug contains on MAOI ask your doctor or pharmacist before taking this product
- if you have a chronic pulmonary disease or shortness of breath unless directed by a doctor
- avoid alcoholic beverages while you are taking this product
- do not use with any other drug containing Acetaminophen (prescirption or nonprescription). If you are not sure whether a drug contains Acetaminophen, ask a doctor or a pharmacist.
Ask the doctor before use if you have
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
- heart disease, high blood pressure, thyroid disease, or difficulty in urination due to the enlargement of prostate gland.
- The user has liver disease
- The user is taking the blood thinning drug Warfarin.
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BRONCOMAR
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53113-215 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg in 10 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 13.33 mg in 10 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg in 10 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 10 mL Inactive Ingredients Ingredient Name Strength ALOE VERA WHOLE (UNII: KIZ4X2EHYX) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C RED NO. 40 (UNII: WZB9127XOA) HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53113-215-06 1 in 1 CARTON 1 177 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/01/2014 Labeler - Gadal Laboratories Inc (841305639)