ROBAFEN- guaifenesin solution

United States - English - NLM (National Library of Medicine)

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Active ingredient:
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)
Available from:
Major Pharmaceuticals
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Expectorant helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
Authorization status:
OTC monograph final
Authorization number:
0904-6763-16, 0904-6763-20

ROBAFEN- guaifenesin solution

Major Pharmaceuticals

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.

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Major Pharmaceuticals Robafen

Drug Facts

Active ingredient (in each 10 mL)

Guaifenesin, USP 200 mg

Purpos e

Expectorant

Us e

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings

Ask a doctor before use if you have

Stop use and ask a doctor if

cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.

A persistent cough may be a sign of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

dose

adults and children 12 years and over

10 – 20 mL every 4 hours

children under 12 years

do not use

cough that occurs with too much phlegm (mucus)

cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or

emphysema

do not take more than 6 doses in any 24-hour period

measure only with dosing cup provided

keep dosing cup with product

mL = milliliter

this adult product is not intended for use in children under 12 years of age

Other information

Inactive ingredients

anhydrous citric acid, caramel, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, maltol,

menthol, propylene glycol, purified water, saccharin sodium, sodium benzoate

Questions or comments?

1-800-616-2471

Principal Display Panel

ROBAFEN

Congestion Formula

Guaifenesin, USP 200 mg

Expectorant

Relieves:

Mucus

Chest Congestion

Cherry Flavor

Dosing Cup Included

Alcohol Free

For Adults Ages 12 and Over

4 FL OZ (118 mL)

store at 20-25 C (68-77 F). Do not refrigerate.

ROBAFEN

guaifenesin solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 9 0 4-6 76 3

Route of Administration

ORAL

Major Pharmaceuticals

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

GUAIFENESIN (UNII: 49 5W7451VQ) (GUAIFENESIN - UNII:49 5W7451VQ)

GUAIFENESIN

20 0 mg in 10 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

CARAMEL (UNII: T9 D9 9 G2B1R)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

GLYCERIN (UNII: PDC6 A3C0 OX)

HIGH FRUCTO SE CO RN SYRUP (UNII: XY6 UN3QB6 S)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

MALTO L (UNII: 3A9 RD9 2BS4)

MENTHO L, UNSPECIFIED FO RM (UNII: L7T10 EIP3A)

Product Characteristics

Color

RED (dark)

S core

S hap e

S iz e

Flavor

CHERRY

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 9 0 4-6 76 3-20

1 in 1 CARTON

0 8 /13/20 18

1

118 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:0 9 0 4-6 76 3-16

473 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

12/10 /20 18

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

0 8 /13/20 18

Labeler -

Major Pharmaceuticals (191427277)

Revised: 6/2020

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