Adult Bisolvine

Adult Bisolvine
SPL v1
SPL
SPL Set ID 8cde5e39-a338-45af-b847-3823627f29c5
Route
ORAL
Published
Effective Date 2025-08-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (200 mg)
Inactive Ingredients
Citric Acid Monohydrate Fd&c Red No. 40 Methylparaben Propylene Glycol Propylparaben Water Sucrose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-01

Description

Active Ingredients (in each 10 mL)                  Purpose Guaifenesin 200 mg ................................................ Expectorant Dextromethorphan HBr 20mg.............................................. Cough Suppressant


Medication Information

Warnings and Precautions

Warnings: Do not exceed recommended dosage.



A persistent or chronic cough may be a sign of a serious condition. If cough persists for more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.

Dosage and Administration

Directions  



    * Do not exceed 6 doses in 24 hours



Age                                                                    Dose



Adults and Children                              2 teaspoonfuls (10 ml)

12 years of age and over                       every 4 hours



Children under 12 years of age                Do not use

Description

Active Ingredients (in each 10 mL)                  Purpose Guaifenesin 200 mg ................................................ Expectorant Dextromethorphan HBr 20mg.............................................. Cough Suppressant

Section 50565-1

Keep out of reach of children

Section 50570-1

Do not use:



    * this product for persistent or chronic cough, such as occurs with smoking, asthma, or emphysema or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor.

    * 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.

Section 51727-6

citric acid, fd&c red No.40, methyl paraben, propylene glycol, propylparaben, water, sucrose

Section 51945-4

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Section 55105-1

Uses



    * temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold and helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

Section 55106-9

Active Ingredients (in each 10 mL)                  Purpose



Guaifenesin 200 mg ................................................ Expectorant



Dextromethorphan HBr 20mg.............................................. Cough Suppressant

Other Information

Other Information

  •   store this product between (15 to 30 C) (59 to 86 C)

Distributed by Menper Distributors, Inc.

6500 N.W. 35th Ave., Miami, Fl, 33147

www.menperdistributors.com


Structured Label Content

Dosage and Administration (34068-7)

Directions  



    * Do not exceed 6 doses in 24 hours



Age                                                                    Dose



Adults and Children                              2 teaspoonfuls (10 ml)

12 years of age and over                       every 4 hours



Children under 12 years of age                Do not use

Warnings and Precautions (34071-1)

Warnings: Do not exceed recommended dosage.



A persistent or chronic cough may be a sign of a serious condition. If cough persists for more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 50570-1 (50570-1)

Do not use:



    * this product for persistent or chronic cough, such as occurs with smoking, asthma, or emphysema or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor.

    * 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.

Section 51727-6 (51727-6)

citric acid, fd&c red No.40, methyl paraben, propylene glycol, propylparaben, water, sucrose

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Section 55105-1 (55105-1)

Uses



    * temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold and helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

Section 55106-9 (55106-9)

Active Ingredients (in each 10 mL)                  Purpose



Guaifenesin 200 mg ................................................ Expectorant



Dextromethorphan HBr 20mg.............................................. Cough Suppressant

Other Information

Other Information

  •   store this product between (15 to 30 C) (59 to 86 C)

Distributed by Menper Distributors, Inc.

6500 N.W. 35th Ave., Miami, Fl, 33147

www.menperdistributors.com


Advanced Ingredient Data


Raw Label Data

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