NDC | 72689-0043-1 |
Set ID | 84a633dc-bd63-0571-e053-2a91aa0a6df8 |
Category | HUMAN OTC DRUG LABEL |
Packager | OASIS TRADING |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
-
INDICATIONS & USAGE
■ adult and children 15 years of age and older: 1envelop twice daily
■ children 11 to under 15 years of age: 2/3 envelop twice daily
■ children 7 to under 11 years of age: 1/2 envelop twice daily
■ children 3 to under 7 years of age: 1/3 envelop twice daily
■ children under 3 years of age: ask a doctor -
WARNINGS
Do not use laxative products when abdominal pain, nausea or vomiting are present unless directed by a doctor
Ask a doctor before use if you have noticed a sudden change in bowel habits that persists over a period of 2 weeks
Ask a doctor before use if you have noticed a sudden change in bowel habits that persists over a period of 2 weeks
When using this product
Do not use for a period longer than 1 weeks
Stop use and ask a doctor if rectal bleeding or failure to have a bowel movement occur after use of a laxative. These may be signs of a serious condition
If pregnant or breast-feeding, ask a health professional before use.
keep out of reach of children. In case of overdose, get medical help or contact a poison contral center right away. - INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BYUN RAK
rhubarb, alexandrian senna, peony root, plantago spp., officinal magnolia, magnoliae cortex, aloe granuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72689-0043 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SENNA LEAF (UNII: AK7JF626KX) (SENNA LEAF - UNII:AK7JF626KX) SENNA LEAF 500 mg in 4 g ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9) ALOE 200 mg in 4 g MAGNOLIA OFFICINALIS BARK (UNII: 5M609NV974) (MAGNOLIA OFFICINALIS BARK - UNII:5M609NV974) MAGNOLIA OFFICINALIS BARK 200 mg in 4 g PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P) (PAEONIA LACTIFLORA ROOT - UNII:3Z3866YW6P) PAEONIA LACTIFLORA ROOT 200 mg in 4 g RHUBARB (UNII: G280W4MW6E) (RHUBARB - UNII:G280W4MW6E) RHUBARB 200 mg in 4 g PLANTAGO INDICA SEED COAT (UNII: I93093PU3S) (PLANTAGO INDICA SEED COAT - UNII:I93093PU3S) PLANTAGO INDICA SEED COAT 2000 mg in 4 g Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) STARCH, CORN (UNII: O8232NY3SJ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72689-0043-1 20 in 1 BOX 11/13/2018 1 4 g in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/13/2018 Labeler - OASIS TRADING (689991468) Registrant - OASIS TRADING (689991468) Establishment Name Address ID/FEI Business Operations OASIS TRADING 689991468 manufacture(72689-0043) , label(72689-0043)