Label: ACETAMINOPHEN FOR ADULTS- acetaminophen suppository
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Contains inactivated NDC Code(s)
NDC Code(s): 68784-113-10, 68784-113-50 - Packager: Acino Products, LLC
- Category: HUMAN OTC DRUG LABEL
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 3, 2016
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug factsActive ingredient (in each 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
- an adult or child 12 years and older takes more than 6 doses in 24 hours, which is the maximum daily amount
- taken with other drugs containing acetaminophen
- an adult takes 3 or more alcoholic drinks every day while using this product
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
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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Acetaminophen Suppositories For Adults product label
Acino Products
NDC 68784-113-10
*Compare to the active ingredient in Fever All
For Adults
Acetaminophen Suppositories USP, 650 mg
Pain reliever/Fever reducer
Ages 12 and over
See New Warning
10 Rectal Suppositories 650 mg each
Tamper-evident: Suppositories are individually wrapped. Do not use if printed wrapper is opened or damaged
READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND INFORMATION
Acino Products LLC
9B 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 ADULTS
acetaminophen suppositoryProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68784-113 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 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:68784-113-10 10 in 1 BOX; Type 0: Not a Combination Product 12/29/2015 2 NDC:68784-113-50 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(68784-113)