0752-Rugby

Drug Labeling and Warnings

Drug Details [pdf]

ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE- acetaminophen, diphenhydramine hydrochloride tablet, film coated 
Rugby Laboratories

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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0752-Rugby

Drug Facts

Active ingredients (in each captab)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Purposes

Pain reliever

Nighttime sleep aid

Uses

temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

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 product containing diphenhydramine, even one used on skin
  • in children under 12 years of age
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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.

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

Other information

  • store at room temperature

croscarmellose sodium, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, mineral oil, polyvinylpyrrolidone, pregelatinized starch, silica, sodium starch glycolate, stearic acid, talc, titanium dioxide, triacetin

Questions or comments?

Call (800) 645-2158

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

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

COMPARE TO THE ACTIVE INGREDIENTS IN EXTRA STRENGTH TYLENOL ® PM*

Rugby ®

NDC: 0536-1173-06

See New Warnings Information & Directions

Acetaminophen 500 mg & Diphenhydramine HCI 25 mg

Pain Rekiever/ Sleep Aid

50 Caplets

0752-rugby-label

ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE 
acetaminophen, diphenhydramine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0536-1173
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
POVIDONE K30 (UNII: U725QWY32X)  
TRIACETIN (UNII: XHX3C3X673)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorblueScoreno score
ShapeOVALSize17mm
FlavorImprint Code CPC752
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0536-1173-0650 in 1 BOTTLE; Type 0: Not a Combination Product08/31/201805/03/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34308/31/201805/03/2019
Labeler - Rugby Laboratories (079246066)

Revised: 5/2019
 

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