ROBITUSSIN CHEST CONGESTION- guaifenesin liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)

Available from:

Wyeth Consumer Healthcare LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Authorization status:

Export only

Summary of Product characteristics

ROBITUSSIN CHEST CONGESTION- GUAIFENESIN LIQUID
WYETH CONSUMER HEALTHCARE LLC
----------
ROBITUSSIN CHEST CONGESTION
PRINCIPAL DISPLAY PANEL - 118 ML BOTTLE LABEL
4 FL OZ (118mL)
Robitussin
(GUAIFENESIN SYRUP, USP)
EXPECTORANT
DIRECTIONS: Follow dosage below:
Do Not Exceed Recommended Dosage.
ADULT DOSE (and children 12 years and
over): 2 - 4 teaspoonfuls every 4 hours.
CHILD DOSE
6 yrs. to under 12 yrs.:
1 - 2 teaspoonfuls every 4 hours.
Children under 6 yrs.:
Do not use.
TAMPER-EVIDENT BOTTLE CAP.
IF BREAKABLE RING IS
SEPARATED, DO NOT USE.
PRINCIPAL DISPLAY PANEL - 118 ML BOTTLE CARTON
Robitussin
(GUAIFENESIN
SYRUP, USP)
®
®
®
EXPECTORANT
LOOSENS and RELIEVES
CHEST CONGESTION
ALCOHOL-FREE
COUGH FORMULA
For Children and Adults
4 FL OZ (118 mL)
PRINCIPAL DISPLAY PANEL - LEAFLET
ROBITUSSIN CHEST CONGESTION
guaifenesin liquid
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:0 0 31-8 748
Wyeth Consumer Healthcare LLC
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)
HIGH FRUCTO SE CO RN SYRUP (UNII: XY6 UN3QB6 S)
DEXTRO SE, UNSPECIFIED FO RM (UNII: IY9 XDZ35W2)
MENTHO L, UNSPECIFIED FO RM (UNII: L7T10 EIP3A)
PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)
SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)
SO DIUM BENZO ATE (UNII: OJ245FE5EU)
WATER (UNII: 0 59 QF0 KO0 R)
PRODUCT CHARACTERISTICS
COLOR
RED
S CORE
S HAP E
S IZ E
FLAVOR
RASPBERRY
IMPRINT CODE
CONTAINS
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:0 0 31-8 748 -0 4
1 in 1 CARTON
0 9 /0 9 /20 13
1
118 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING EN