देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
Active Ingredients . . . . . . . .Purpose Sorbitol 70% . . . . . . . . . . . . .Laxative
Geritrex LLC
ORAL
OTC DRUG
For occasional relief of constipation.
OTC monograph not final
SORBITOL- SORBITOL SOLUTION GERITREX LLC _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._ ---------- SORBITOL SOLUTION ACTIVE INGREDIENTS Active Ingredients . . . . . . . .Purpose Sorbitol 70% . . . . . . . . . . . . .Laxative US ES For occasional relief of constipation. DIRECTIONS For adults or children 12 years or over. Use 2-4 TBSP (30-60ml) daily or as directed by a Physician. Use 2-4 TBSP (30-60ml) daily or as directed by a Physician. WARNINGS This product does not contain a child resistant cap. Keep out of reach of children. In case of accidental overdose, contact a doctor or a poison control center. Cautions Stop use if you are having rectal bleeding or failure to have a bowel movement after use. If adverse effects call 1-800-736- 3437 Unless directed by your doctor Do not take any laxative if you are having abdominal pain, nausea, or vomiting. Laxative products should not be used longer than a week. Ask a pharmacist or doctor if • You have noticed a sudden change in bowel habits that persist over two weeks after using this product. • You are pregnant or breast feeding before use. Water Store at room temperature (59°F-86°F). Below 59°F cloudiness may occur. Application of heat may restore clarity and fluidity without affecting the quality of Sorbitol. DO NOT FREEZE. Keep out of reach of children. In case of accidental overdose, contact a doctor or a poison control center. SORBITOL sorbitol solution PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:5416 2-70 0 ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH SO RBITO L (UNII: 50 6 T6 0 A25R) (SORBITOL - UNII:50 6 T6 0 A25R) SORBITOL 258 .2 g in 474 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH WATER (UNII: 0 59 QF0 KO0 R) Geritrex LLC PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING EN पूरा दस्तावेज़ पढ़ें