Berro Y Cebolla

Berro Y Cebolla
SPL v5
SPL
SPL Set ID 20107bd9-6d84-4ab5-a0d9-966f1f11d919
Route
ORAL
Published
Effective Date 2022-02-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Guaifenesin (100 mg)
Inactive Ingredients
Aloe Ascorbic Acid Cat's Claw Corn Syrup Diacetyltartaric And Fatty Acid Esters Of Glycerol Alcohol Eucalyptus Alba Leaf Fd&c Blue No. 1 Fd&c Yellow No. 5 Garlic Ginger Acacia Honey Menthol Methylparaben Onion Peppermint Polysorbate 80 Potassium Sorbate Propylene Glycol Propylparaben Sodium Benzoate Sucralose Sunflower Oil Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-04-01

Description

Dextromethorphan HBr - 10mg Guaifenesin - 100mg

Purpose

Cough Suppressant Expectorant


Medication Information

Purpose

Cough Suppressant

Expectorant

Description

Dextromethorphan HBr - 10mg Guaifenesin - 100mg

Uses

- temporarily relieves cough as may occur with the common cold

- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus

Section 51945-4

Directions

shake well before use

do not exceed more than 6 doses in any 24-hour period or as directed by a doctor.

AGE                                                                                       Dose

adults and children 12 years of age and over                             2 tablespoons (30 mL) every 4 hours

children 6 to under 12 years of age                                           1 tablespoon (15 mL) every 4 hours

children under 6 years of age                                                   consult a doctor

Other Information

store between 15° - 30° C (59° - 86° F)

Tamper-Evident Feature: Do not use this product if printed safety seal over cap is torn, broken or missing.

Inactive Ingredients

Aloe leaf extract, ascorbic acid, cat's claw bark extract, corn syrup, DATEM, ethyl alcohol (0.15%), eucalyptus, FD&C blue #1, FD&C yellow #5, garlic bulb extract, ginger root extract, gum arabic, honey, menthol, methylparaben, onion bulb fluid extract, peppermint leaf fluid extract, polysorbate 80, potassium sorbate, propylene glycol, propylparaben, sodium benzoate, sucralose, sunflower oil, water.

Questions Or Comments?

1-800-560-5223 M-F 9 AM to 4 PM Eastern

Stop Use and Ask A Doctor If
  • cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition
  • nervousness, dizziness, or sleeplessness occurs
Keep Out of Reach of Children.

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Active Ingredients in Each 15ml

Dextromethorphan HBr - 10mg

Guaifenesin - 100mg

If Pregnant Or Breast Feeding 

ask a health professional before use.

Do Not Exceed Recommended Dosage

Do not use

if you are now taking a prescription monamine 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.

Ask A Doctor Before Use If You Have

a persistent or chronic cough

a cough that is accompanied by excessive phlegm (mucus)

a breathing problem such as occurs with smoking, asthma, chronic bronchitis, or emphysema


Structured Label Content

Uses

- temporarily relieves cough as may occur with the common cold

- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus

Section 51945-4 (51945-4)

Purpose

Cough Suppressant

Expectorant

Directions

shake well before use

do not exceed more than 6 doses in any 24-hour period or as directed by a doctor.

AGE                                                                                       Dose

adults and children 12 years of age and over                             2 tablespoons (30 mL) every 4 hours

children 6 to under 12 years of age                                           1 tablespoon (15 mL) every 4 hours

children under 6 years of age                                                   consult a doctor

Other Information (Other information)

store between 15° - 30° C (59° - 86° F)

Tamper-Evident Feature: Do not use this product if printed safety seal over cap is torn, broken or missing.

Inactive Ingredients (Inactive ingredients)

Aloe leaf extract, ascorbic acid, cat's claw bark extract, corn syrup, DATEM, ethyl alcohol (0.15%), eucalyptus, FD&C blue #1, FD&C yellow #5, garlic bulb extract, ginger root extract, gum arabic, honey, menthol, methylparaben, onion bulb fluid extract, peppermint leaf fluid extract, polysorbate 80, potassium sorbate, propylene glycol, propylparaben, sodium benzoate, sucralose, sunflower oil, water.

Questions Or Comments? (Questions or Comments?)

1-800-560-5223 M-F 9 AM to 4 PM Eastern

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition
  • nervousness, dizziness, or sleeplessness occurs
Keep Out of Reach of Children. (Keep out of reach of children.)

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Active Ingredients in Each 15ml (Active Ingredients in each 15mL)

Dextromethorphan HBr - 10mg

Guaifenesin - 100mg

If Pregnant Or Breast Feeding  (If pregnant or breast-feeding )

ask a health professional before use.

Do Not Exceed Recommended Dosage (Do not exceed recommended dosage)

Do not use

if you are now taking a prescription monamine 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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

a persistent or chronic cough

a cough that is accompanied by excessive phlegm (mucus)

a breathing problem such as occurs with smoking, asthma, chronic bronchitis, or emphysema


Advanced Ingredient Data


Raw Label Data

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