Label: HEALTH MART FIBER CAPLETS- methylcellulose tablet
- NDC Code(s): 62011-0134-1
- Packager: Strategic Sourcing Services LLC
- 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.
Updated January 7, 2022
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- Active ingredient (in each caplet)
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
- abdominal pain, nausea or vomiting
- a sudden change in bowel habits that persists over a period of 2 weeks
When using this product
- do not use laxative products for a period longer than one week unless directed by a doctor
- do not use if you are on a low salt diet unless directed by a doctor
Stop use and ask a doctor if
- rectal bleeding occurs
- you fail to have a bowel movement after use
These could be signs of a serious condition.
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
HEALTH MART FIBER CAPLETS
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62011-0134 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYLCELLULOSE (4000 CPS) (UNII: MRJ667KA5E) (METHYLCELLULOSE (4000 CPS) - UNII:MRJ667KA5E) METHYLCELLULOSE (4000 CPS) 500 mg Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSPOVIDONE (UNII: 2S7830E561) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM LAURYL SULFATE (UNII: 368GB5141J) Product Characteristics Color orange Score no score Shape CAPSULE Size 19mm Flavor Imprint Code G188 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62011-0134-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 10/18/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 10/18/2019 Labeler - Strategic Sourcing Services LLC (116956644) Registrant - Guardian Drug Company (119210276) Establishment Name Address ID/FEI Business Operations Guardian Drug Company 119210276 manufacture(62011-0134)