Indications and uses
Temporarily relieves minor aches and pains due to: • headache • a cold • arthritis • muscular aches • toothache • premenstrual & menstrual cramps
Temporarily relieves minor aches and pains due to: • headache • a cold • arthritis • muscular aches • toothache • premenstrual & menstrual cramps
• 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
• 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.
Drug Facts
Acetaminophen 250mg
Aspirin 250mg (NSAID*)
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Pain reliever
Pain reliever
Pain reliever aid
Temporarily relieves minor aches and pains due to:
• headache • a cold • arthritis • muscular aches • toothache • premenstrual & menstrual cramps
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.
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.
• 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
• 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.
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
1-833-665-9444. (Mon-Fri 9am-5pm)
Drug Facts
Diphenhydramine HCl 25mg
Antihistamine
• 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
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.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
• 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 |
• 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.
croscarmellose sodium, dicalcium phosphate, D&C red No.27 aluminium lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide
1-833-665-9444.
(Mon-Fri 9am - 5pm)
Drug Facts
Acetaminophen 500mg
Diphenhydramine HCl 25mg
Pain reliever
Nighttime sleep aid
• temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
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.
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.
• 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 |
• Store at room temperature between 20-25°C (68-77°F).
• avoid excessive heat, cold and humidity.
• close cap tightly after use.
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.
1-833-665-9444. (Mon-Fri 9am-5pm)
Drug Facts
Acetaminophen 500mg
Pain reliever / Fever reducer
• 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.
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.
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.
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 |
• Store at room temperature between 20-25°C (68-77°F).
• avoid excessive heat, cold and humidity.
• close cap tightly after use.
hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide
1-833-665-9444. (Mon-Fri 9am-5pm)
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
Packaged By: Strive Pharmaceuticals Inc.
East Brunswick, NJ 08816.
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 308297 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet | PSN | 2 |
| 1092189 | acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral Tablet | PSN | 2 |
| 198440 | acetaminophen 500 MG Oral Tablet | PSN | 2 |
| 1049630 | diphenhydrAMINE HCl 25 MG Oral Tablet | PSN | 2 |
| 308297 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet | SCD | 2 |
| 1092189 | acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet | SCD | 2 |
| 198440 | acetaminophen 500 MG Oral Tablet | SCD | 2 |
| 1049630 | diphenhydramine hydrochloride 25 MG Oral Tablet | SCD | 2 |
| 308297 | APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral Tablet | SY | 2 |
| 1092189 | APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet | SY | 2 |
| 198440 | APAP 500 MG Oral Tablet | SY | 2 |
| Class | Version | Type | Effective |
|---|---|---|---|
| ASPIRIN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20191108 |
| CAFFEINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 73006-350-98 | 2023-01-30 | C162847 | 48780-1 | f386c64a-20fc-0266-e053-dadaa90a7c1a | Only For ™ FIRST AID + MEDICINE KIT |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 73006-120-95 | Only For FIRST AID MEDICINE | 1 in 1 CARTON | TABLET | 500 mg | 2 | |
| 73006-120-95 | Only For FIRST AID MEDICINE | 25 in 1 BOTTLE, PLASTIC | TABLET | 25 | 500 mg | 2 |
| 73006-132-95 | Only For FIRST AID MEDICINE | 1 in 1 CARTON | TABLET | 65 mg | 2 | |
| 73006-132-95 | Only For FIRST AID MEDICINE | 25 in 1 BOTTLE, PLASTIC | TABLET | 25 | 250 mg | 2 |
| 73006-143-95 | Only For FIRST AID MEDICINE | 25 in 1 BOTTLE, PLASTIC | TABLET | 25 | 500 mg | 2 |
| 73006-143-95 | Only For FIRST AID MEDICINE | 1 in 1 CARTON | TABLET | 500 mg | 2 | |
| 73006-148-95 | Only For FIRST AID MEDICINE | 25 in 1 BOTTLE, PLASTIC | TABLET | 25 | 25 mg | 2 |
| 73006-148-95 | Only For FIRST AID MEDICINE | 1 in 1 CARTON | TABLET | 25 mg | 2 | |
| 73006-350-98 | Only For FIRST AID MEDICINE | 1 in 1 BOX | KIT | 1 | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 73006-120 | ONLY FOR FIRST AID MEDICINE (DIPHENHYDRAMINE HCL, ACETAMINOPHEN, ASPIRIN, CAFFEINE) KIT [O4 GLOBAL TRADING USA, LLC] | 2 | Legacy NDC | 20201224_e647a322-9d90-40d1-9199-a87c4bf069e3.zip |
| 73006-132 | ONLY FOR FIRST AID MEDICINE (DIPHENHYDRAMINE HCL, ACETAMINOPHEN, ASPIRIN, CAFFEINE) KIT [O4 GLOBAL TRADING USA, LLC] | 2 | Legacy NDC | 20201224_e647a322-9d90-40d1-9199-a87c4bf069e3.zip |
| 73006-143 | ONLY FOR FIRST AID MEDICINE (DIPHENHYDRAMINE HCL, ACETAMINOPHEN, ASPIRIN, CAFFEINE) KIT [O4 GLOBAL TRADING USA, LLC] | 2 | Legacy NDC | 20201224_e647a322-9d90-40d1-9199-a87c4bf069e3.zip |
| 73006-148 | ONLY FOR FIRST AID MEDICINE (DIPHENHYDRAMINE HCL, ACETAMINOPHEN, ASPIRIN, CAFFEINE) KIT [O4 GLOBAL TRADING USA, LLC] | 2 | Legacy NDC | 20201224_e647a322-9d90-40d1-9199-a87c4bf069e3.zip |
| 73006-350 | ONLY FOR FIRST AID MEDICINE (DIPHENHYDRAMINE HCL, ACETAMINOPHEN, ASPIRIN, CAFFEINE) KIT [O4 GLOBAL TRADING USA, LLC] | 2 | Legacy NDC, 9 package rows | 20201224_e647a322-9d90-40d1-9199-a87c4bf069e3.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 73006-350 | 73006-350-98 |
| 73006-132 | 73006-132-95 |
| 73006-148 | 73006-148-95 |
| 73006-120 | 73006-120-95 |
| 73006-143 | 73006-143-95 |
Every source-derived ingredient row is available through these pages.
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| fad34fa0-43a6-49c4-8241-e8402b569254 | e647a322-9d90-40d1-9199-a87c4bf069e3 | 2020-12-23 | Warnings | fad34fa0-43a6-49c4-8241-e8402b569254 e647a322-9d90-40d1-9199-a87c4bf069e3 |
Adverse event summaries are temporarily unavailable. Other product information remains available.