RUGBY ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG PAIN RELIEVER/SLEEP AID- acetaminophen,diphenhydramine hcl tablet, film coated

Rugby Acetaminophen 500 mg and by

Drug Labeling and Warnings

Rugby Acetaminophen 500 mg and by is a Otc medication manufactured, distributed, or labeled by RUGBY LABORATORIES. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each Captab)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

PURPOSE

Purposes

Pain Reliever

Nighttime Sleep Aid

INDICATIONS & USAGE

Uses

Temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.

WARNINGS

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.
• in children under 12 years of age
• with any other product containing diphenhydramine, even one used on skin
• 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
• difficulty in urination due to enlargement of the 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 a serious underlying medical illness.
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts 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 warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION

​Directions

• Do not take more than directed (see overdose warning)

Adults and children 12 years and over: Take 2 captabs at bedtime. Do not take more than 2 captabs of this product in 24 hours

Children under 12 years: do not use

STORAGE AND HANDLING

Other information

• Store at room temperature
  

INACTIVE INGREDIENT

Inactive ingredients Croscarmellose sodium, crospovidone, FD&C blue #1, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, silica, sodium starch glycolate, stearic acid and titanium dioxide.

QUESTIONS

Questions or comments? Call 1-800-645-2158

SPL UNCLASSIFIED SECTION

Do not use if imprinted safety seal under cap is broken or missing

Distributed by: Rugby Laboratories

17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152

www.rugbylaboratories.com

PRINCIPAL DISPLAY PANEL

COMPARE TO ACTIVE INGREDIENTS IN EXTRA STRENGTH Tylenol® PM*

Rugby®

NDC: 0536-1015-06

See New Warnings Information & Directions

Acetaminophen 500 mg and Diphenhydramine HCl 25 mg

Pain Reliever / Sleep Aid

50 CAPTABS

* Rugby Laboratories is not affiliated with the owner of the registered trademark Tylenol®

INGREDIENTS AND APPEARANCE

RUGBY ACETAMINOPHEN 500 MG AND  DIPHENHYDRAMINE HCL 25 MG PAIN RELIEVER/SLEEP AID
acetaminophen,diphenhydramine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1015
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE (UNII: 68401960MK)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	blue (Film Coated)	Score	no score
Shape	CAPSULE (Capsule Shaped Tablet)	Size	18mm
Flavor		Imprint Code	GP325
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1015-06	50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/26/2014	10/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	08/26/2014	10/31/2020

Labeler - RUGBY LABORATORIES (079246066)