BERRO Y CEBOLLA DM- dextromethorphan hydrobromide, guaifenesin liquid

Berro y Cebolla by

Drug Labeling and Warnings

Berro y Cebolla by is a Otc medication manufactured, distributed, or labeled by Menper Distributors, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients in each 15mL

Dextromethorphan HBr - 10mg

Guaifenesin - 100mg

Purpose

Cough Suppressant

Expectorant

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

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

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

If pregnant or breast-feeding 

ask a health professional before use.

Keep out of reach of children.

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BERRO Y CEBOLLA  DM
dextromethorphan hydrobromide, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53145-080
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 15 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE (UNII: V5VD430YW9)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CAT'S CLAW (UNII: 9060PRM18Q)
CORN SYRUP (UNII: 9G5L16BK6N)
DIACETYLTARTARIC AND FATTY ACID ESTERS OF GLYCEROL (UNII: 248HN3Z28U)
ALCOHOL (UNII: 3K9958V90M)
EUCALYPTUS ALBA LEAF (UNII: 2JEJ1KEK9A)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
GARLIC (UNII: V1V998DC17)
GINGER (UNII: C5529G5JPQ)
ACACIA (UNII: 5C5403N26O)
HONEY (UNII: Y9H1V576FH)
MENTHOL (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
ONION (UNII: 492225Q21H)
PEPPERMINT (UNII: V95R5KMY2B)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUNFLOWER OIL (UNII: 3W1JG795YI)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53145-080-08	1 in 1 CARTON	04/01/2019
1		237 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	04/01/2019

Labeler - Menper Distributors, Inc. (101947166)