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Guaifenesin

Professional Labeling Information and Directions for Use These products labeled for sale on prescription only. Guaifenesin Tablets

Approved
Approval ID

78987a51-82f7-4ca6-80ad-fa22d1f3e11a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 6, 2010

Manufacturers
FDA

Contract Pharmacy Services-PA

DUNS: 945429777

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

guaifenesin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code67046-250
Product Classification
G
Generic Name
guaifenesin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 18, 2009
FDA Product Classification

INGREDIENTS (8)

CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
GUAIFENESINActive
Quantity: 200 mg in 1 1
Code: 495W7451VQ
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT

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