Micro-Coated Aspirin by Rugby Laboratories, Inc / Time Cap Labs, Inc RUGBY 11R

Micro-Coated Aspirin by

Drug Labeling and Warnings

Micro-Coated Aspirin by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories, Inc, Time Cap Labs, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MICRO-COATED ASPIRIN- aspirin tablet, coated 
Rugby Laboratories, Inc

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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RUGBY 11R

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/Fever reducer

Uses

temporarily relieves

• headache
• minor pain of arthritis
• toothache
• muscle pain
• pain and fever of colds
• menstrual pain

Warnings

Reye's syndrome:

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert:

Aspirin may cause a severe allergic reaction which may include

• hives
• facial swelling
• shock
• asthma (wheezing)

Stomach bleeding warning:

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if the user:

• is age 60 or older
• has had stomach ulcers or bleeding problems
• takes a blood thinning (anticoagulant) or steroid drug
• takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
• takes more or for a longer time than directed
• has 3 or more alcoholic drinks every day while using this product

Ask a doctor before use if

• stomach bleeding warning applies to user
• user has a history of stomach problems, such as heartburn
• user has high blood pressure, heart disease, liver cirrhosis, or kidney disease
• user is taking a diuretic
• user has asthma
• user has not been drinking fluids
• user has lost a lot of fluid due to vomiting or diarrhea
  

Ask a doctor or pharmacist before use if the user is

• taking a prescription drug for diabetes, gout, or arthritis
• taking any other drug
• under a doctor's care for any serious condition
  

Stop use and ask a doctor if

• user experiences any of the following signs of stomach bleeding:
• • feels faint
  • has bloody or black stools
  • vomits blood
  • has stomach pain that does not get better
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present in the painful area
• any new symptoms appear
• ringing in the ears or a loss of hearing occurs
  

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

RUGBY 11R

Directions

DRINK A FULL GLASS OF WATER WITH EACH DOSE

• adults and children 12 years and over: 1 or 2 tablets every 4 hours while symptoms last, not more than 12 tablets in 24 hours
• children under 12 years: ask a doctor

Other information

• store at 20°-25°C (68°-77°F)
• coated for easier swallowing
  

Inactive ingredients

corn starch, croscarmellose sodium, hypromellose, microcrystalline cellulose, mineral oil, titanium dioxide

Questions or comments?

call

1-800-645-2158

, 9 am - 5 pm ET, Monday - Friday

MICRO-COATED ASPIRIN 
aspirin tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-3305
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	TCL;011
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-3305-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/21/2011	01/01/2018
2	NDC: 0536-3305-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	09/21/2011	01/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	09/21/2011	01/01/2018

Labeler - Rugby Laboratories, Inc (079246066)

Registrant - Time Cap Labs, Inc (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
Time Cap Labs, Inc		037052099	manufacture(0536-3305)

Revised: 11/2019

Document Id: 97f20f5f-960c-a033-e053-2995a90a6d90

34390-5

Set id: 89a96333-97c2-4fb4-a5d3-a2c829a63685

Version: 2

Effective Time: 20191122

 

Rugby Laboratories, Inc