ONLY FOR HEADACHE- acetaminophen, aspirin, caffeine tablet

ONLY FOR HEADACHE by

Drug Labeling and Warnings

ONLY FOR HEADACHE by is a Otc medication manufactured, distributed, or labeled by O4 Global Trading Usa, Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each geltab)

Acetaminophen 250mg

Aspirin 250mg (NSAID*)

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Pain reliever

Pain reliever aid

Uses:

Temporarily relieves minor aches and pains due to:

headache a cold arthritis muscular aches toothache premenstrual & menstrual cramps

Warnings:

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flue-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

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.

Allergy alert: Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 geltabs 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

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed

Caffeine warning: ​The recommended dose of this product contains about a much caffeine as 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  if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if  you have liver disease  stomach bleeding warning applies to you  you have a history of stomach problems, such as heartburn  you have high blood pressure, heart disease, liver cirrhosis, or kidney disease  you are taking a diuretic  you have asthma

Ask a doctor or pharmacist before use if you are taking

a prescription drug for diabetes, gout, or arthritis

any other drug, or are under a doctor's care for any serious condition

Stop use and ask a doctor if  an allergic reaction occurs. Seek medical help right away.  you experience any of the following signs of stomach bleeding:  feel faint  vomit blood  have bloody or black stools  have stomach pain that does not get better  ringing in the ears or loss of hearing occurs  painful area is red or swollen  pain gets worse or lasts for more than 10 days  fever gets worse or lasts for more than 3 days  any new symptoms occur

These could be signs of a serious condition

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or compliments during delivery.

Keep out of reach of children.

OVERDOSE WARNING: Taking more than directed can cause serious health problems. In case overdose. get medical help or contact a Poison Control Center right away.

Directions:

do not use more than directed

drink a full glass of water with each dose

adults and children 12 years and over: take 2 geltabs every 6 hours; not more than 8 geltabs in 24 hours

children under 12 years: ask a doctor

Other Information:

store at room temperature between 20-25°C (68 to 77°F)  avoid excessive heat, cold and humidity  close cap tightly after use  read all product information before using.

Inactive Ingredients:

ammonium hydroxide, black iron oxide, brilliant blue FCF, corn starch, D&C yellow No.10 lake, ethyl cellulose, FD&C blue No.1 lake, FD&C red No.40 lake, gelatin, glycerin, hydroxypropyl methyl cellulose, isopropyl alcohol, isopropyl alcohol - butyl alcohol, lactose monohydrate, light liquid paraffin, microcrystalline cellulose, polysorb 85/70/00, povidone K30, pregelatinised starch, propylene glycol, purified water, shellac glaze, stearic acid, talc, titanium dioxide, triacetin

Questions or comments?

1-833-665-9444. (Mon-Fri 9am-5pm)

SPL UNCLASSIFIED SECTION

ADULT

PAIN RELIEVER

PAIN RELIEVER AID

TAMPER EVIDENT: Do not use if imprinted safety seal under cap is broken or missing

Distributed By: O4 GLOBAL TRADING USA, LLC.

12222 Merit Drive, Suite 1900

Dallas, TX 75251-3209

www.onlyfor.com

Packaged By: Strive Pharmaceuticals Inc.

East Brunswick, NJ 08816.

Packaging 

INGREDIENTS AND APPEARANCE

ONLY FOR HEADACHE 
acetaminophen, aspirin, caffeine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73006-132
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	250 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65 mg

Inactive Ingredients
Ingredient Name	Strength
AMMONIA (UNII: 5138Q19F1X)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
STARCH, CORN (UNII: O8232NY3SJ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSES (UNII: 3NXW29V3WO)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SHELLAC (UNII: 46N107B71O)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	green (Dark Green - White)	Score	no score
Shape	ROUND	Size	13mm
Flavor		Imprint Code	S77
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73006-132-95	1 in 1 CARTON	11/15/2020
1		25 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	11/15/2020

Labeler - O4 Global Trading Usa, Llc (081226861)