ONLY FOR BODY PAIN- acetaminophen, diphenhydramine hcl tablet

Only For by

Drug Labeling and Warnings

Only For 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 500 mg

Diphenhydramine HCl 25 mg

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 1,000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks everyday 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
• for more than 10 days for pain unless directed by a doctor
• for more than 3 days for fever unless directed by a doctor

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 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 continously 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 Warning: 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:
  • 2 caplets at bedtime
  • do not take more than 2 caplets 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).

Inactive Ingredients:

Colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, hydroxypropyl methyl cellulose, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide.

Questions Or Comments ?

1-833-665-9444.

SPL UNCLASSIFIED SECTION

NDC: 73006-119-41

Distributed By: O4 GLOBAL TRADING USA LLC., 2241 S Watson RD, Suite 121 Arlington, TX 76010.

www.onlyfor.com

Packaged By: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816.

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING.

Tear along perforation push product through foil

Packaging

INGREDIENTS AND APPEARANCE

ONLY FOR  BODY PAIN
acetaminophen, diphenhydramine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73006-119
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--ALUMINUM LAKE (UNII: J9EQA3S2JM)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
MAGNESIUM PALMITOSTEARATE (UNII: R4OXA9G5BV)
STARCH, CORN (UNII: O8232NY3SJ)
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL (Caplet)	Size	12mm
Flavor		Imprint Code	AD01
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73006-119-41	1 in 1 CARTON	03/29/2019
1		4 in 1 BLISTER PACK; 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	03/29/2019

Labeler - O4 Global Trading Usa, Llc (081226861)