Label: QUALITY CHOICE FIBER THERAPY- methylcellulose tablet
- NDC Code(s): 63868-078-10
- Packager: Chain Drug Marketing Association Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated July 29, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT(in each caplet)
- PURPOSE
- USE(S)
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WARNINGS
Choking: Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting or difficulty in swallowing or breathing after taking this product, seek immediate medical attention.
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN
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DIRECTIONS
This product generally produces effect in 12-72 hours
- take this product (child or adult) dose with atleast 8 ounces (a full glass) of water or other fluid
- taking this product without enough liquid may cause choking, see choking warning.
AGE DOSE MAXIMUM DOSE adults & children 12 years & over 2 caplets up to 6 times daily children 6 to 11 years 1 caplet up to 6 times daily children under 6 years ask a doctor ask a doctor
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
QUALITY CHOICE FIBER THERAPY
methylcellulose tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-078 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYLCELLULOSE (4000 MPA.S) (UNII: MRJ667KA5E) (METHYLCELLULOSE (4000 MPA.S) - UNII:MRJ667KA5E) METHYLCELLULOSE (4000 MPA.S) 500 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSPOVIDONE (UNII: 68401960MK) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM CHLORIDE (UNII: 451W47IQ8X) Product Characteristics Color ORANGE Score no score Shape CAPSULE Size 18mm Flavor Imprint Code G188 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-078-10 100 in 1 BOTTLE; Type 0: Not a Combination Product 07/28/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 07/28/2022 Labeler - Chain Drug Marketing Association Inc. (011920774)