FDA Label for Foster And Thrive Ready To Use Saline Laxative
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- USE
- DOSAGE WARNING
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU
- OTC - ASK DOCTOR/PHARMACIST
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS (OR AS DIRECTED BY A DOCTOR)
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL - 133 ML BOTTLE CARTON
Foster And Thrive Ready To Use Saline Laxative Product Label
The following document was submitted to the FDA by the labeler of this product Mckesson. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Distributed by: McKesson Corp., via Strategic
Sourcing Services LLC. Memphis, TN 38141
Otc - Purpose
| Active ingredients (in each 118mL delivered dose) | Purpose |
|---|---|
| Dibasic Sodium Phosphate 7 g | Saline laxative |
| Monobasic Sodium Phosphate 19 g | Saline laxative |
Use
- relieves occasional constipation
- this product generally produces bowel movement in 1 to 5 minutes
Dosage Warning
Using more than one enema in 24 hours can be harmful.
For rectal use only.
Do Not Use
- on children under 2 years of age
Ask A Doctor Before Use If You
- have already used a laxative for more than 3 days
- have kidney disease, have heart problems, or are dehydrated
- are 55 years of age or older
- are on a sodium-restricted diet
- have abdominal pain, nausea, or vomiting
- have a sudden change in bowel habits lasting more than 2 weeks
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.
When Using This Product
- do not use more than directed. Serious side effects may occur from excess dosage
- do not use for more than 3 days, without asking a doctor
Stop Use And Ask A Doctor If
- you have rectal bleeding
- you have no bowel movement within 30 minutes of enema use
- you have symptoms of dehydration (thirstiness, dizziness, vomiting, urinating less often than normal)
These symptoms may indicate a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.
Directions (Or As Directed By A Doctor)
Single daily dosage (per 24 hours) Do not use if taking another sodium phosphate product. Do not use more unless directed by a doctor. See Warnings.
| Adults and children 12 years of age and older | 1 bottle once daily |
| Children 2 to under 12 years of age | Use Pediatric Enema |
| Children under 2 years of age | DO NOT USE |
Other Information
- each 118 ml contains sodium 4.3 g
- store at 15 to 30°C (59 to 86°F)
- additional liquids by mouth are recommended while using this product
- Tamper Evident: DO NOT USE IF TOP OR BOTTOM FLAP OF CARTON IS TORN OR MISSING.
Inactive Ingredients
benzalkonium chloride, disodium EDTA, purified water
Questions Or Comments?
833-358-6431
Principal Display Panel - 133 Ml Bottle Carton
NDC 70677-1089-1
COMPARE TO FLEET®
SALINE ENEMA
ACTIVE INGREDIENTS*
Foster & Thrive™
READY TO USE
Enema
SALINE LAXATIVE
Lubricated Tip
Works In Minutes
Not Made With
Natural Rubber Latex
For Relief of:
- Occassional
Constipation
NOT ACTUAL SIZE
1 BOTTLE
4.5 FL OZ (133 mL)
* Please review the disclaimer below.
