ONLY FOR HEADACHE- acetaminophen, caffeine 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.

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Only For - HEADACHE

DRUG FACTS

Active ingredient (in each caplet)

Acetaminophen 500mg

Caffeine 65mg

Purpose

Pain reliever

Pain reliever aid

Uses:

Warnings:

Liver warning:

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

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. 

Caffeine warning:

The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally rapid heart beat. 

Do not use

Ask a doctor before use if

you have liver disease

Ask a doctor or pharmacist before use if,

you are taking the blood thinning drug warfarin

Stop use and ask a doctor if

• any new symptoms occur     • pain gets worse or lasts for more than 10 days

• fever gets worse or lasts for more than 3 days

These could be signs of a serious condition

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of childern

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:

 adults and children 12 years of age and over take 2 caplets every 6 hours, not more than 6 caplets in 24 hours.
 under 12 years of age ask a doctor

Other Information:

Inactive Ingredients:

colloidal silicon dioxide, croscarmellose sodium, D&C red #27 aluminum lake, FD&C yellow #6 aluminum lake, gelatin, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, purified water, sodium starch glycolate, talc, titanium dioxide.

Questions Or Comments ?

1-833-665-9444.

NDC: 73006-110-41

ADULT

ANALGESIC(PAIN RELIEVER)

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

image description

ONLY FOR  HEADACHE
acetaminophen, caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73006-110
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
MAGNESIUM PALMITOSTEARATE (UNII: R4OXA9G5BV)  
STARCH, CORN (UNII: O8232NY3SJ)  
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYVINYL ALCOHOL (94000 MW) (UNII: C1MS7RRZ6L)  
WATER (UNII: 059QF0KO0R)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorredScoreno score
ShapeOVAL (Caplet) Size18mm
FlavorImprint Code S777
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73006-110-411 in 1 CARTON03/29/2019
14 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34303/29/2019
Labeler - O4 Global Trading Usa, Llc (081226861)

Revised: 5/2019
Document Id: d4563ca7-c1d2-4056-baa4-6edf8719cec4
Set id: bd4d089c-3953-4b49-9df6-e8722eec4418
Version: 1
Effective Time: 20190509
 
O4 Global Trading Usa, Llc