Label: BRONCOMAR EXPECTORANT- acetaminofen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 70242-102-06 - Packager: Dannso Corp./d.b.a. Essential Products
- 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 January 1, 2016
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ACTIVE INGREDIENT
Active Ingredients:(in each 10 ml.) Purpose Acetaminophen 250 mg ........................................................
Analgesic
Dextromethorphan Hydrobromide 13.33 mg .......................
Cough Suppressant
Guaifenesin USP 200 mg......................................................
Expectorant
Phenylephrine HCl 5 mg.......................................................
Decongestant
- PURPOSE
- WARNINGS
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DO NOT USE
- 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 every day 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
- 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 MAOI drug.
- If you do not know if your prescription drug contains MAOI as 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 beverage while taking this product.
- Do not use with any other drug containing Acetaminophen (prescription no nonprescription) If you are not sure whether a drug contains Acetaminophen, ask a doctor or pharmacist
Stop use and ask a doctor
- Nervousness, dizziness or sleeplessness occurs.
- Cough persists more than 1 week, tends to recur or is accompanied by a fever, rash or persistent headache. A persistent cough may be signserious condition.
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ASK DOCTOR
Ask doctor before use if you have
- Cough that occurs with too much phlegm(mucus)
- Cough that last or is a chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.
- Heart disease, high blood pressure, thyroid disease, or difficulty in urination due enlargement of prostate gland.
- The user has Liver diseases
- The user us taking the blood thinning drug Warfarin
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- Inactive Ingredient
- Questions or Comments
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BRONCOMAR EXPECTORANT
acetaminofen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70242-102 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 LEAF (UNII: ZY81Z83H0X) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C RED NO. 40 (UNII: WZB9127XOA) HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70242-102-06 1 in 1 CARTON 01/01/2015 1 177 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 10/01/2001 Labeler - Dannso Corp./d.b.a. Essential Products (059741071) Registrant - Dannso Corp./d.b.a. Essential Products (059741071) Establishment Name Address ID/FEI Business Operations All Pharma LLC 078572520 MANUFACTURE(70242-102)