ACETAMINOPHEN 80 MG FRUIT CHEW- acetaminophen tablet

ACETAMINOPHEN 80 MG FRUIT CHEW by

Drug Labeling and Warnings

ACETAMINOPHEN 80 MG FRUIT CHEW by is a Otc medication manufactured, distributed, or labeled by Proficient Rx LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Acetaminophen USP, 80 mg

Purposes

Pain Reliever/Fever Reducer

Uses

temporarily reduces fever and relieves minor aches and pains caused by

• headache
• the common cold
• flu
• toothache
• sore throat

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if the child takes

• more than 5 doses in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen

OTHER SAFETY INFORMATION

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.

OTHER SAFETY INFORMATION

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

DO NOT USE

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

ASK DOCTOR

Ask a doctor before use if the child has liver disease

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin

Drug Facts continued on back of label

STOP USE

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
• redness or swelling is present
• any new symptoms appear

These could be signs of a serious condition

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick 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 take more than directed (see Overdose warning)
• find correct dose on chart below
• if possible, use weight to dose, otherwise use age
• chew tablets before swallowing
• give dose every 4 hours while symptoms last
• do not give more than 5 doses in 24 hours

Weight (pounds)	Age (years)	Dose (tablets)
72-95	11-12	4-6
60-71	9-10	4-5
48-59	6-8	4
36-47	4-5	3
24-35	2-3	2
under 24	under 2	ask a doctor

Other information

• Phenylketonurics: each tablet contains: phenylalanine 5 mg

Other information

• store at room temperature 15°-30°C (59°-86°F)

Inactive ingredients

aspartame, compressible sugar, D&C red #27 (Al-lake), dextrose, FD&C yellow #6 (Al-lake), flavors, magnesium stearate, microcrystalline cellulose, stearic acid

Questions or comments?

call 516-341-0666 8:30 am - 4:30 pm ET, Monday - Friday

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

SPL UNCLASSIFIED SECTION

*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Tylenol®.

Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580

Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320

PRINCIPAL DISPLAY PANEL

NDC: 63187-944-30

FRUIT FLAVORED

Acetominophen USP 80 mg

PAIN RELIEVER

FEVER REDUCER

30 CHEWABLE TABLETS

*Compare to Active Ingredient in Children's TYLENOL®

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 80 MG FRUIT CHEW 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63187-944(NDC:69618-012)
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)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
D&C RED NO. 27 (UNII: 2LRS185U6K)
STEARIC ACID (UNII: 4ELV7Z65AP)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
SUCROSE (UNII: C151H8M554)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63187-944-20	20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2018
2	NDC: 63187-944-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2018
3	NDC: 63187-944-40	40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2018
4	NDC: 63187-944-50	50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2018
5	NDC: 63187-944-60	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	11/01/2015

Labeler - Proficient Rx LP (079196022)

Establishment
Name	Address	ID/FEI	Business Operations
Proficient Rx LP		079196022	REPACK(63187-944) , RELABEL(63187-944)