AUROPHEN PM EXTRA STRENGTH- acetaminophen and diphenhydramine hcl tablet

Aurophen PM Extra Strength by

Drug Labeling and Warnings

Aurophen PM Extra Strength by is a Otc medication manufactured, distributed, or labeled by Aurohealth LLC, APL HEALTHCARE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each caplet)

Acetaminophen USP 500 mg
Diphenhydramine HCl USP 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 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 lasts 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 overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick 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 and over:
  • take 2 caplets at bedtime
  • do not take more than 2 caplets of this product in 24 hours
• children under 12 years: do not use

Other information

• each caplet contains: sodium 1.36 mg
• store between 20-25°C (68-77°F)
• do not use if carton is opened, or seal under cap is torn or missing.

Inactive ingredients

colloidal silicon dioxide, corn starch, FD&C blue No. 1 aluminum lake, FD&C blue No. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polysorbate 80, potassium sorbate, povidone, propylene glycol, purified water, sodium starch glycolate, titanium dioxide, triacetin

Questions or comments?

1-855-274-4122

Distributed by:
Aurohealth LLC.
2572 Brunswick Pike
Lawrenceville, NJ 08648

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 100 Caplets

AUROHEALTH

NDC: 58602-743-21

*Compare to the active ingredient in TYLENOL ® PM Extra Strength

Extra Strength
Pain Reliever, Nighttime Sleep Aid
AUROPHEN PM
Acetaminophen and

Diphenhydramine HCl Caplets

500 mg/25 mg

Non-habit forming

100 Caplets

INGREDIENTS AND APPEARANCE

AUROPHEN PM EXTRA STRENGTH 
acetaminophen and diphenhydramine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-743
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)
STARCH, CORN (UNII: O8232NY3SJ)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	BLUE (Light Blue)	Score	no score
Shape	CAPSULE (Biconvex)	Size	18mm
Flavor		Imprint Code	N35
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-743-07	1 in 1 CARTON	02/24/2016
1		24 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 58602-743-14	1 in 1 CARTON	02/24/2016
2		50 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 58602-743-21	1 in 1 CARTON	02/24/2016
3		100 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 58602-743-29	150 in 1 BOTTLE; Type 0: Not a Combination Product	02/24/2016
5	NDC: 58602-743-34	200 in 1 BOTTLE; Type 0: Not a Combination Product	02/24/2016
6	NDC: 58602-743-35	225 in 1 BOTTLE; Type 0: Not a Combination Product	02/24/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	02/24/2016

Labeler - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurohealth LLC		078728447	MANUFACTURE(58602-743)