ACETAMINOPHEN 80 MG FRUIT CHEW- acetaminophen tablet 
Proficient Rx LP

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 USP 80 MG FRUIT CHEW TABLET

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

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, 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 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 a doctor before use if the child has liver disease

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 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.

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

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

*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

63187-944-30NDC 63187-944-30

FRUIT FLAVORED

Acetominophen USP 80 mg

PAIN RELIEVER

FEVER REDUCER

30 CHEWABLE TABLETS

*Compare to Active Ingredient in Children's TYLENOL®

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
Image of Product
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 079502574 REPACK(63187-944) , RELABEL(63187-944)

Revised: 12/2018
Document Id: 8db578e6-5219-4409-99d5-c5bcb25a8608
Set id: 7a5f9416-a11d-45fb-bc1a-bd2991d1c10e
Version: 2
Effective Time: 20181201
 
Proficient Rx LP