CHEWABLE ACETAMINOPHEN CHILDRENS- acetaminophen tablet, chewable

Chewable Acetaminophen by

Drug Labeling and Warnings

Chewable Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Richmond Pharmaceuticals, Inc., Advance Pharmaceutical Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Acetaminophen 80 mg

Purpose

Pain reliever/fever reducer

Uses

• temporarily relieves minor aches and pains due to:
• headache
• sore throat
• flu
• toothache
• the common cold
• temporarily reduces fever

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.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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.
• if your child is allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if your child has

liver disease.

Ask a doctor or pharmacist before use if your child is

taking the blood thinning drug warfarin.

When using this product

do not exceed recommended dosage.

Stop use and ask a doctor if

• pain gets worse or lasts more than 5 days
• fever gets worse or lasts more than 3 days
• new symptoms occur
• redness or swelling is present

These could be signs of a serious condition.

Keep out of reach of children.

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

Directions

• this product does not contain directions or complete warnings for adult use
• do not give more than directed
• find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
• chew before swallowing; this product will soften in mouth for ease of chewing
• repeat dose every 4 hours while symptoms last
• do not give more than 5 times in 24 hours
• do not give for more than 5 days unless directed by a doctor

Weight (lb)	Age (yr)	Dose (tablets)*
Under 24	Under 2	Ask a doctor
24-35	2-3	2
36-47	4-5	3
48-59	6-8	4
60-71	9-10	4-5
72-95	11-12	4-6

*or as directed by a doctor

Other information

• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• avoid high humidity
• Phenylketonurics:each tablet contains: phenylalanine 5mg

Inactive ingredients

aspartame, compressible sugar, D&C red #27(Al lake), dextorse, FD&C yellow #6(Al lake), fruit flavor, magnesium stearate, microcrystaline cellulose, prosweet, stearice acid

Questions or comments?

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday

Principal display panel

NDC- 54738-092-30 -  APAP 80MG CHEWABLE- 30 TABS

INGREDIENTS AND APPEARANCE

CHEWABLE ACETAMINOPHEN  CHILDRENS
acetaminophen tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54738-092
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	80 mg

Inactive Ingredients
Ingredient Name	Strength
ASPARTAME (UNII: Z0H242BBR1)
INVERT SUGAR (UNII: ED959S6ACY)
D&C RED NO. 27 (UNII: 2LRS185U6K)
DEXTROSE (UNII: IY9XDZ35W2)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	pink (light)	Score	2 pieces
Shape	ROUND	Size	10mm
Flavor	FRUIT	Imprint Code	AP;051
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54738-092-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	04/01/2015

Labeler - Richmond Pharmaceuticals, Inc. (043569607)

Registrant - Advance Pharmaceutical Inc. (078301063)

Establishment
Name	Address	ID/FEI	Business Operations
Advance Pharmaceutical Inc.		078301063	manufacture(54738-092)