Only For FIRST AID MEDICINE

Manufacturer
O4 Global Trading Usa, Llc
Effective date
2020-12-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:35:51

Label at a glance#

ProductOnly For FIRST AID MEDICINE
Active ingredientACETAMINOPHEN, ASPIRIN, CAFFEINE, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure40 sections

Indications and uses

Temporarily relieves minor aches and pains due to: • headache • a cold • arthritis • muscular aches • toothache • premenstrual & menstrual cramps

Dosage and administration

• 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

Storage and handling

• 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.           

Label contents#

Full prescribing information#

ONLY FOR HEADACHE- acetaminophen, aspirin, caffeine tablet

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each geltab)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 250mg

Aspirin 250mg (NSAID*)

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever

Pain reliever

Pain reliever aid

Uses:

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and pains due to:

• headache • a cold • arthritis • muscular aches • toothache • premenstrual & menstrual cramps

Warnings:

WARNINGS SECTION

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, 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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:

DOSAGE & ADMINISTRATION SECTION

• 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:

STORAGE AND HANDLING SECTION

• 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:

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

ONLY FOR ALLERGY- diphenhydramine hcl tablet

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses:

INDICATIONS & USAGE SECTION

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
   • runny nose
   • sneezing
   • itchy, watery eyes
   • itching of the nose or throat

• temporarily relieves these symptoms due to the common cold:
   • runny nose
   • sneezing

Warnings:

WARNINGS SECTION

Do not use
• to make a child sleepy
• with any other product containing diphenhydramine, even one used on skin.

Ask a doctor before use if you have
• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are 

taking sedatives or tranquilizers

When using this product
• marked drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children.

If pregnant or breast-feeding,
ask a health professional before use.

SPL UNCLASSIFIED SECTION

Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.             

Directions:

DOSAGE & ADMINISTRATION SECTION

• take every 4 to 6 hours, or as directed by doctor

• do not take more than 6 doses in 24 hours

 adults and children 12 years and over• take 1 to 2 caplets
 children 6 to under 12 years • take 1 caplet

Other Information:

STORAGE AND HANDLING SECTION

• store between 20-25°C (68-77°F) excursions permitted between 15-30°C (59-86°F).
• avoid excessive heat and light.
• store in dry place.           

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dicalcium phosphate, D&C red No.27 aluminium lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

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

ONLY FOR BODY PAIN- acetaminophen, diphenhydramine hcl tablet

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500mg

Diphenhydramine HCl 25mg

Purpose

OTC - PURPOSE SECTION

Pain reliever

Nighttime sleep aid

Uses:

INDICATIONS & USAGE SECTION

• temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Warnings:

WARNINGS SECTION

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

• more than 4,000 mg of acetaminophen in 24 hours

• 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.

• with any other product containing diphenhydramine, even one used on skin

• in children under 12 years of age

• if you have ever had any allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have

• liver disease

• a breathing problem such as emphysema or chronic bronchitis

• trouble urinating due to an enlarged prostate gland

• glaucoma.

Ask a doctor or pharmacist before use if

• you are taking the blood thinning drug warfarin

• taking sedatives or tranquilizers.

When using this product

• drowsiness will occur

• avoid alcoholic drinks

• do not drive a motor vehicle or operate machinery.

Stop use and ask a doctor if

• sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

• pain gets worse or lasts more than 10 days

• fever gets worse or last more than 3 days

If pregnant or breast-feeding, ask a health professional before use.             

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSE WARNINGS: 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:

DOSAGE & ADMINISTRATION SECTION

• take with a full glass of water

• Do not take more than directed. SEE OVERDOSE WARNING.

• do not take more than 2 caplets in 24 hours

adults and children 12 years of age and over• take 2 caplets at bedtime

• do not take more than 2 caplets of this product in 24 hours

children under 12 years of age• do not use

Other Information:

STORAGE AND HANDLING SECTION

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

• avoid excessive heat, cold and humidity.

• close cap tightly after use.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, FD&C blue No.1, hydroxy propyl methyl cellulose, magnesium stearate, starch, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide.

Questions or comments?

OTC - QUESTIONS SECTION

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

ONLY FOR FEVER- acetaminophen tablet

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500mg

Purpose

OTC - PURPOSE SECTION

Pain reliever / Fever reducer

Uses:

INDICATIONS & USAGE SECTION

• temporary relief minor aches and pains due to:

   • the common cold

   • backache

   • toothache

   • premenstrual and menstrual cramps

   • temporarily reduces fever.

   • headache

   • minor pain of arthritis

   • muscular aches

   • premenstrual and menstrual cramps

• temporarily reduces fever.

Warnings:

WARNINGS SECTION

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

• more than 4,000 mg of acetaminophen in 24 hours

• 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 have ever had any allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have liver disease

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

Stop use and ask a doctor if

• pain gets worse or lasts more than 10 days

• fever gets worse or last more than 3 days

• new symptoms occur.

• redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. OVERDOSE WARNINGS: 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:

DOSAGE & ADMINISTRATION SECTION

Do not take more than directed. SEE OVERDOSE WARNING.

 adults and children 12 years of age and over• take 2 caplets every 6 hours while symptoms last

• do not take more than 6 caplets in 24 hours, unless directed by doctor

• do not take more than 10 days, unless directed by a doctor

 children under 12 years of age• ask a doctor

Other Information:

STORAGE AND HANDLING SECTION

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

• avoid excessive heat, cold and humidity.

• close cap tightly after use.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Only For™  FIRST AID + MEDICINE KIT

4 SOLUTIONS

HEADACHE 25 Geltabs

ACETAMINOPHEN 250mg / Aspirin (NSAID) 250mg / Caffeine 65mg

ALLERGY 25 Caplets

Diphenhydramine HCl 25mg

BODY PAIN 25 Caplets

ACETAMINOPHEN 500mg / Diphenhydramine HCl 25mg

FEVER 25 Caplets

ACETAMINOPHEN 500mg

FOR DRUG INFORMATION REVIEW, CHECK BOTTLES THAT COME INSIDE THE BOX


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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANELPACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANELPACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletPSN2
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN2
198440acetaminophen 500 MG Oral TabletPSN2
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN2
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCD2
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD2
198440acetaminophen 500 MG Oral TabletSCD2
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD2
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSY2
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY2
198440APAP 500 MG Oral TabletSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASPIRIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108
CAFFEINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73006-350-982023-01-30C16284748780-1f386c64a-20fc-0266-e053-dadaa90a7c1a​ Only For ™ FIRST AID + MEDICINE KIT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73006-120-95Only For FIRST AID MEDICINE1 in 1 CARTONTABLET500 mg2
73006-120-95Only For FIRST AID MEDICINE25 in 1 BOTTLE, PLASTICTABLET25500 mg2
73006-132-95Only For FIRST AID MEDICINE1 in 1 CARTONTABLET65 mg2
73006-132-95Only For FIRST AID MEDICINE25 in 1 BOTTLE, PLASTICTABLET25250 mg2
73006-143-95Only For FIRST AID MEDICINE25 in 1 BOTTLE, PLASTICTABLET25500 mg2
73006-143-95Only For FIRST AID MEDICINE1 in 1 CARTONTABLET500 mg2
73006-148-95Only For FIRST AID MEDICINE25 in 1 BOTTLE, PLASTICTABLET2525 mg2
73006-148-95Only For FIRST AID MEDICINE1 in 1 CARTONTABLET25 mg2
73006-350-98Only For FIRST AID MEDICINE1 in 1 BOXKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73006-120ONLY FOR FIRST AID MEDICINE (DIPHENHYDRAMINE HCL, ACETAMINOPHEN, ASPIRIN, CAFFEINE) KIT [O4 GLOBAL TRADING USA, LLC]2Legacy NDC20201224_e647a322-9d90-40d1-9199-a87c4bf069e3.zip
73006-132ONLY FOR FIRST AID MEDICINE (DIPHENHYDRAMINE HCL, ACETAMINOPHEN, ASPIRIN, CAFFEINE) KIT [O4 GLOBAL TRADING USA, LLC]2Legacy NDC20201224_e647a322-9d90-40d1-9199-a87c4bf069e3.zip
73006-143ONLY FOR FIRST AID MEDICINE (DIPHENHYDRAMINE HCL, ACETAMINOPHEN, ASPIRIN, CAFFEINE) KIT [O4 GLOBAL TRADING USA, LLC]2Legacy NDC20201224_e647a322-9d90-40d1-9199-a87c4bf069e3.zip
73006-148ONLY FOR FIRST AID MEDICINE (DIPHENHYDRAMINE HCL, ACETAMINOPHEN, ASPIRIN, CAFFEINE) KIT [O4 GLOBAL TRADING USA, LLC]2Legacy NDC20201224_e647a322-9d90-40d1-9199-a87c4bf069e3.zip
73006-350ONLY FOR FIRST AID MEDICINE (DIPHENHYDRAMINE HCL, ACETAMINOPHEN, ASPIRIN, CAFFEINE) KIT [O4 GLOBAL TRADING USA, LLC]2Legacy NDC, 9 package rows20201224_e647a322-9d90-40d1-9199-a87c4bf069e3.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 47 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 61 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
fad34fa0-43a6-49c4-8241-e8402b569254e647a322-9d90-40d1-9199-a87c4bf069e32020-12-23WarningsExact identifier
spl id: fad34fa0-43a6-49c4-8241-e8402b569254
spl set id: e647a322-9d90-40d1-9199-a87c4bf069e3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.