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TAMPER EVIDENT, INDIVIDUALLY SEALED FOR YOUR PROTECTION
Proctozone-g Suppository
FDA Label NDC 57237-338
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rising Pharma Holdings, Inc. for the product Proctozone-g (NDC 57237-338). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient (in each suppository)
Glycerin USP, 1.2 grams
Otc - Purpose
Purpose
Laxative
Indications & Usage
Uses
- For relief of occasional constipation
- This product usually produces bowel movement in 1/4 to 1 hour
Warnings
Warnings
For rectal use only
Otc - Do Not Use
Do not use for longer than 1 week unless directed by a doctor.
Otc - Ask Doctor
Ask a doctor before use if the child has
- Stomach pain, nausea or vomiting
- A sudden change in bowel habits lasting more than 2 weeks
Otc - When Using
When using this product your child may have rectal discomfort or a burning sensation
Otc - Stop Use
Stop use and ask a doctor if you have
- Rectal bleeding
- No bowel movement after using this product
These may indicate a serious condition.
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.
Dosage & Administration
Directions
- Tear off one suppository from the strip
- If the suppository seems soft, place it in the refrigerator before use or run cold water over it before removing the foil wrapper
- Gently remove suppository by peeling apart the wrapper (see illustration 1)
- Rub a water-based lubricant over the tip or dip it in water. It will help you slide it in smoothly
- Lie on your side and insert 1 suppository, tapered end first, about the length of your finger into the rectum (see illustration 2)
- Hold the suppository for about 15-20 minutes to allow time for it to melt
- Children 2 to under 6 years of age ...................... 1 suppository once daily
- Children under 2 years ............................................ ask a doctor
Storage And Handling
Other Information
Keep away from excessive heat.
Inactive Ingredient
Inactive ingredients
purified water, sodium stearate.
Otc - Questions
Questions or Comments:
call 1-844-474-7464
Package Label.Principal Display Panel
NDC 57237-338-21 (2 blisters of 6 suppositories)
Proctozone-GTM
GLYCERIN SUPPOSITORIES 1.2 g
RECTAL LAXATIVE
Front Foil (57237-338-16)
Back Foil (57237-338-16)
NDC 57237-338-52 (5 blisters of 5 suppositories)
Front Foli (57237-338-51)
Back Foil (57237-338-51)
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