ONLY FOR BODY PAIN- acetaminophen, diphenhydramine hcl tablet

Only For BODY PAIN by

Drug Labeling and Warnings

Only For BODY PAIN 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 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 an 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

redness or swelling is present

new symptoms occur.

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:

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)

SPL UNCLASSIFIED SECTION

ADULT

PAIN RELIEVER NIGHTTIME SLEEP 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 BODY PAIN 
acetaminophen, diphenhydramine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	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	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)