GERI-TUSSIN EXPECTORANT- guaifenesin liquid

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

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Active ingredient:
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)
Available from:
REMEDYREPACK INC.
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:
70518-1970-0, 70518-1970-1

GERI-TUSSIN EXPECTORANT- guaifenesin liquid

REMEDYREPACK INC.

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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Active ingredient (per teaspoonful = 5mL)

Guaifenesin, USP 100 mg

Purpos e

Expectorant

Us es

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

Warnings

Do not use if you are hypersensitive to any of the ingredients

Ask a doctor before use if you have

cough that occurs with too much phlegm (mucus)

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

emphysema

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever,

rash, or persistent headache. These could be signs 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.

Directions

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

do not exceed recommended dose

adults and children 12 years and

over

2-4 teaspoonfuls every 4

hours

children under 12 years

ask a doctor

Other information

store at room temperature 15º - 30ºC (59º - 86ºF)

protect from freezing

protect from light

TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF BREAKAWAY BAND ON CAP IS

BROKEN OR MISSING

Inactive ingredients

citric acid, caramel, FD and C Red 40, flavor, glycerin, menthol, sodium saccharin, sodium benzoate,

sorbitol, water

DRUG: GERI-TUSSIN EXPECTORANT

GENERIC: Guaifenesin

DOSAGE: LIQUID

ADMINSTRATION: ORAL

NDC: 70518-1970-0

NDC: 70518-1970-1

COLOR: red

FLAVOR: CHERRY

PACKAGING: 10 in 1 BOX, UNIT-DOSE

PACKAGING: 20 mL in 1 CUP UNIT DOSE

ACTIVE INGREDIENT(S):

GUAIFENESIN 100mg in 5mL

INACTIVE INGREDIENT(S):

ANHYDROUS CITRIC ACID

SACCHARIN SODIUM

SODIUM BENZOATE

SORBITOL

MENTHOL

CARAMEL

FD&C RED NO. 40

GLYCERIN

WATER

GERI-TUSSIN EXPECTORANT

guaifenesin liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 518 -19 70 (NDC:578 9 6 -79 3)

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

GUAIFENESIN

10 0 mg in 5 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)

MENTHO L (UNII: L7T10 EIP3A)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

SO RBITO L (UNII: 50 6 T6 0 A25R)

WATER (UNII: 0 59 QF0 KO0 R)

Product Characteristics

Color

re d

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:70 518 -19 70 -

10 in 1 BOX, UNIT-DOSE

0 3/20 /20 19

1

NDC:70 518 -19 70 -

20 mL in 1 CUP, UNIT-DOSE; Type 0 : No t a Co mbinatio n

Pro duc t

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 3/20 /20 19

REMEDYREPACK INC.

Labeler -

REMEDYREPACK INC. (829572556)

Revised: 3/2019

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