RUGBY ACETAMINOPHEN- acetaminophen tablet

Rugby Acetaminophen by

Drug Labeling and Warnings

Rugby Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Uses

• temporarily relieves minor aches and pains due to:
• headache
• muscular aches
• backache
• minor pain of arthritis
• the common cold
• toothache
• premenstrual and menstrual cramps
• temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

• adult takes more than 4,000 mg of acetaminophen in 24 hours
• child takes more than 5 doses in 24 hours
• taken with other drugs containing acetaminophen
• adult has 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.
• if the user has ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if the user

• has liver disease
• is a child with pain of arthritis

Ask a doctor or pharmacist before use if the user is

taking the blood thinning drug warfarin

Stop use and ask a doctor if

• pain gets worse or lasts more than 10 days (for adults) or 5 days (for children)
• 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 tablets every 4 to 6 hours while symptoms last do not take more than 10 tablets in 24 hours do not use for more than 10 days unless directed by a doctor
	children 6-11 years	take 1 tablet every 4 to 6 hours while symptoms last do not take more than 5 tablets in 24 hours do not use for more than 5 days unless directed by a   doctor
	children under 6 years	ask a doctor

Inactive ingredients

croscarmellose sodium*, povidone, pregelatinized starch, stearic acid

*may contain this ingredient

Questions or comments?

1-800-645-2158

Principal Display Panel

COMPARE TO ACTIVE INGREDIENT IN REGULAR STRENGTH TYLENOL®

REGULAR STRENGTH

Acetaminophen

WITHOUT ASPIRIN

PAIN RELIEVER/FEVER REDUCER

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

100 Acetaminophen

Tablets 325 mg Each

INGREDIENTS AND APPEARANCE

RUGBY ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1164
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND (beveled edge)	Size	10mm
Flavor		Imprint Code	325MG;L403
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1164-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/16/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	01/16/2019

Labeler - Rugby Laboratories (079246066)