ONLY FOR FEVER- acetaminophen tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
Available from:
O4 Global Trading Usa, Llc
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain Reliever - Fever reducer • temporarily relieves minor aches and pains due to: • the common cold   • headache   • backache   • minor pain of arthritis   • toothache   • muscular aches   • premenstrual and menstrual cramps   • temporarily reduces fever 
Authorization status:
OTC monograph not final
Authorization number:
73006-117-41

ONLY FOR FEVER- acetaminophen tablet

O4 Global Trading Usa, 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.

----------

Only For- FEVER

DRUG FACTS

Active ingredient (in each caplet)

Acetaminophen 500mg

Purpose

Pain Reliever - Fever reducer

Uses:

temporarily relieves minor aches and pains due to:

the common cold headache backache minor pain of arthritis toothache muscular aches

premenstrual and menstrual cramps temporarily reduces fever

Warnings:

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if you take:

more than 3,000mg of acetaminophen in 24 hours, which is the maximum daily amount

with other drugs containing acetaminophen

3 or more alcoholic drinks every day while using this product

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.

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 you are allergic to acetaminophen or any of the inactive ingredients in this product

for more than 10 days for pain unless directed by a doctor

for more than 3 days for fever unless directed by a doctor

Ask a doctor before use if you have

liver disease

Ask a doctor or a pharmacist before use if

you are taking the blood thinning drug warfarin

Stop use and ask a doctor if

symptoms do not improve

new symptoms occur

pain or fever persists or gets worse

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children

Overdose Warning: In case of accidental overdose, get medical help or contact a Poison Control

Center 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:

take with a full glass of water

do not take more than directed (See Overdose Warning)

adults and children 12 years of

age & over

take 2 caplets every 6 hours while symptoms persist.

do not take more than 6 caplets in 24 hours, unless

directed by a doctor

do not use for more than 10 days unless directed by a

doctor

children under 12 years of age

ask a doctor

Other Information:

Store at room temperature between 20-25°C (68-77°F).

Inactive Ingredients:

colloidal silicon dioxide, gelatin, glycerin, hydroxypropyl methyl cellulose, maize starch, magnesium

stearate, purified talc, sodium starch glycolate.

Questions Or Comments ?

1-833-665-9444.

NDC: 73006-117-41

ADULT

PAIN RELIEVER-FEVER REDUCER

Distributed By: O4 GLOBAL TRADING USA LLC., 2241 S Watson RD, Suite 121 Arlington, TX

76010.

www.onlyfor.com

Packaged By: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816.

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF A BLISTER UNIT IS

TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING.

Tear along perforation push product through foil

Packaging

ONLY FOR FEVER

acetaminophen tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:730 0 6 -117

Route of Administration

ORAL

O4 Global Trading Usa, Llc

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

50 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

GELATIN, UNSPECIFIED (UNII: 2G8 6 QN327L)

GLYCERIN (UNII: PDC6 A3C0 OX)

HYPRO MELLO SE 2 9 10 ( 5 MPA.S) (UNII: R75537T0 T4)

STARCH, CO RN (UNII: O8 232NY3SJ)

MAGNESIUM PALMITO STEARATE (UNII: R4OXA9 G5BV)

TALC (UNII: 7SEV7J4R1U)

SO DIUM STARCH GLYCO LATE TYPE A PO TATO (UNII: 58 56 J3G2A2)

Product Characteristics

Color

white

S core

no sco re

S hap e

OVAL (CAPLET)

S iz e

18 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:730 0 6 -117-41 1 in 1 CARTON

0 3/29 /20 19

1

4 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt343

0 3/29 /20 19

Labeler -

O4 Global T rading Usa, Llc (081226861)

Revised: 5/2019

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