ONLY FOR FIRST AID MEDICINE- diphenhydramine hcl, acetaminophen, aspirin, caffeine kit

Only For FIRST AID MEDICINE by

Drug Labeling and Warnings

Only For FIRST AID MEDICINE by is a Otc medication manufactured, distributed, or labeled by O4 Global Trading Usa, Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ONLY FOR HEADACHE- acetaminophen, aspirin, caffeine tablet

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, 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)             

ONLY FOR ALLERGY- diphenhydramine hcl tablet

Drug Facts

Active ingredient (in each caplet)

Diphenhydramine HCl 25mg

Purpose

Antihistamine

Uses:

 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:

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.             

Directions:

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:

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:

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?

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

ONLY FOR BODY PAIN- acetaminophen, diphenhydramine hcl tablet

Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500mg

Diphenhydramine HCl 25mg

Purpose

Pain reliever

Nighttime sleep aid

Uses:

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

Warnings:

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.

Directions:

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:

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

avoid excessive heat, cold and humidity.

close cap tightly after use.

Inactive Ingredients:

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?

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

ONLY FOR FEVER- acetaminophen tablet

Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500mg

Purpose

Pain reliever / Fever reducer

Uses:

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:

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.

Directions:

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:

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

avoid excessive heat, cold and humidity.

close cap tightly after use.

Inactive Ingredients:

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

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ONLY FOR FIRST AID MEDICINE 
diphenhydramine hcl, acetaminophen, aspirin, caffeine kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73006-350

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73006-350-98	1 in 1 BOX; Type 0: Not a Combination Product	11/15/2020

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PLASTIC	25
Part 2	1 BOTTLE, PLASTIC	25
Part 3	1 BOTTLE, PLASTIC	25
Part 4	1 BOTTLE, PLASTIC	25

Part 1 of 4

ONLY FOR HEADACHE 
acetaminophen, aspirin, caffeine tablet

Product Information
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
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

Part 2 of 4

ONLY FOR ALLERGY 
diphenhydramine hcl tablet

Product Information
Item Code (Source)	NDC: 73006-148
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	pink	Score	no score
Shape	OVAL (Caplet)	Size	11mm
Flavor		Imprint Code	DP
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73006-148-95	1 in 1 CARTON
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 final	part338	11/15/2020

Part 3 of 4

ONLY FOR BODY PAIN 
acetaminophen, diphenhydramine hcl tablet

Product Information
Item Code (Source)	NDC: 73006-120
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	blue (LIGHT BLUE)	Score	no score
Shape	capsule	Size	18mm
Flavor		Imprint Code	AD01
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73006-120-95	1 in 1 CARTON
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

Part 4 of 4

ONLY FOR FEVER 
acetaminophen tablet

Product Information
Item Code (Source)	NDC: 73006-143
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	capsule	Size	17mm
Flavor		Imprint Code	S500
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73006-143-95	1 in 1 CARTON
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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part338	11/15/2020

Labeler - O4 Global Trading Usa, Llc (081226861)