Label: ACETAMINOPHEN FOR CHILDREN- acetaminophen suppository
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Contains inactivated NDC Code(s)
NDC Code(s): 68784-112-10, 68784-112-50 - Packager: Acino Products, 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.
Drug Label Information
Updated February 2, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug FactsActive ingredient (in each rectal suppository)
- Purpose
- Keep out of reach of children.
- Uses
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Warnings
Liver warning: This product contains acetaminophen.
Severe liver damage may occur if your child takes:
- more than 5 doses in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
Allergy alert: Acetaminophen may cause severe skin reactions.
Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
For rectal use only.
- Do not use
- Ask a doctor before use if
- Stop use and ask a doctor if
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Directions
- this product does not contain directions or warnings for adult use
- do not use more than directed
- remove wrapper
- carefully insert suppository well up into the rectum
Dosing Chart
Age Dose under 3 years
3 to 6 years
Do not use unless directed by a doctor
Use 1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours)
- Other information
- Inactive ingredients
- Questions or comments?
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Acetaminophen Suppositories For Children product label
Acion Products
NDC 68784-112-10
*Compare to the active ingredient in Fever All
For Children
Acetaminophen Suppositories USP, 120 mg
Pain reliever/Fever reducer
Age 3-6
See New Warning
10 Rectal Suppositories 120 mg each
Tamper-evident: Suppositories are individually wrapped. Do not use if printed wrapper is open or damaged
READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND INFORMATION
Acino Products LLC9B South Gold Drive
Hamilton, NJ 08691.
MADE IN THE USA
*This product is not manufactured or distributed by Acino Mid Atlantic LLC the distributed of Fever All®
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN FOR CHILDREN
acetaminophen suppositoryProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68784-112 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 120 mg Inactive Ingredients Ingredient Name Strength GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) FAT, HARD (UNII: 8334LX7S21) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) POLYSORBATE 80 (UNII: 6OZP39ZG8H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68784-112-10 10 in 1 BOX; Type 0: Not a Combination Product 12/29/2015 2 NDC:68784-112-50 50 in 1 BOX; Type 0: Not a Combination Product 12/29/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 12/29/2015 Labeler - Acino Products, LLC (019385518) Registrant - Acino Products, LLC (019385518) Establishment Name Address ID/FEI Business Operations Acino Products, LLC 019385518 manufacture(68784-112)