ACETAMINOPHEN FOR CHILDREN- acetaminophen suppository

ACETAMINOPHEN by

Drug Labeling and Warnings

ACETAMINOPHEN by is a Otc medication manufactured, distributed, or labeled by Acino Products, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug FactsActive ingredient (in each rectal suppository)

Acetaminophen 120 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

• temporarily reduces fever
• temporarily relieves minor aches, pains and headache

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

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if

• your child has liver disease
• your child is taking the blood thinning drug warfarin

Stop use and ask a doctor if

• fever lasts more than 3 days (72 hours), or recurs.
• pain lasts more than 5 days or gets worse.
• new symptoms occur.
• redness or swelling is present in the painful area.

These could be signs of a serious condition.

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

• store at 20°-25°C (68°-77°F)
• tamper evident suppositories are individually wraped.

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 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 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®

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN  FOR CHILDREN
acetaminophen suppository

Product 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)