Aurophen pm extra strength tablet

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
  • inchildren 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:sodium1.36 mg
  • store between 20-25C (68-77F)
  • do not use if carton isopened, 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

Ingredients and appearance - Product information

Aurophen pm extra strength tablet- Acetaminophen and diphenhydramine hcl

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 58602-743
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 500 mgin 1
Diphenhydramine hydrochloride ( UNII: TC2D6JAD40)( Diphenhydramine - UNII: 8GTS82S83M ) 25 mgin 1

Inactive Ingredients

Ingredient Name Code
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) Shape CAPSULE (Biconvex)
Size 18 mm Score 1
Imprint Code N35

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH NOT FINAL part343 USA

Labeler - Aurohealth LLC( 078728447)

Establishment

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

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