ACETAMINOPHEN FOR ADULTS- acetaminophen suppository 
Acino Products, LLC

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.

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Acetaminophen Suppositories - 113 DPL

Drug facts
Active ingredient (in each suppository)

Acetaminophen 650 mg

Purpose

Pain reliever/fever reducer

Keep out of reach of children.

If swallowed or in case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Uses

Warnings

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if

Allergy alert: Acetaminophen may cause severe skin reactions.

Symptoms may include:

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

These could be signs of a serious condition.

Directions

Other information

Do not use if printed wrapper is open or damaged.

Inactive ingredients

Glycerol Monostearate, Hydrogenated Vegetable Oil, Lecithin, Polysorbate 80

Questions or comments?

Call (609-695-4300)

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®

Acino Acetaminophen 113

ACETAMINOPHEN  FOR ADULTS
acetaminophen suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68784-113
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
FAT, HARD (UNII: 8334LX7S21)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68784-113-1010 in 1 BOX; Type 0: Not a Combination Product12/29/2015
2NDC:68784-113-5050 in 1 BOX; Type 0: Not a Combination Product12/29/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34312/29/2015
Labeler - Acino Products, LLC (019385518)
Registrant - Acino Products, LLC (019385518)
Establishment
NameAddressID/FEIBusiness Operations
Acino Products, LLC019385518manufacture(68784-113)

Revised: 2/2016
Document Id: 4cdf03c7-e115-44f3-9cad-f4b934fac6de
Set id: 49ac0d42-9a30-4f99-84d4-1eb2a0cc849f
Version: 1
Effective Time: 20160203
 
Acino Products, LLC