RUGBY ACETAMINOPHEN- acetaminophen tablet

United States - English - NLM (National Library of Medicine)

Buy It Now

Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
Available from:
Rugby Laboratories
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer
Authorization status:
OTC monograph not final
Authorization number:
0536-1164-01

RUGBY ACETAMINOPHEN- acetaminophen tablet

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.

----------

Rugby Laboratories Acetaminophen Drug Facts

Active ingredient (in each tablet)

Acetaminophen 325 mg

Purpos e

Pain reliever/fever reducer

Us es

Warnings

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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

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

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

skin reddening

blisters

rash

with any other drug containing acetaminophen (prescription or nonprescription). If you are not

sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if the user

Ask a doctor or pharmacist before use if the user is

taking the blood thinning drug warfarin

Stop use and ask a doctor if

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

adults and children 12

years and over

children

6-11 years

children under

6 years

ask a doctor

Inactive ingredients

croscarmellose sodium*, povidone, pregelatinized starch, stearic acid

*may contain this ingredient

if the user has ever had an allergic reaction to this product or any of its ingredients

has liver disease

is a child with pain of arthritis

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

do not take more than directed (see overdose warning)

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

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

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

Rugby Laboratories

RUGBY ACETAMINOPHEN

acetaminophen tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 536 -116 4

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

325 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

ROUND (beveled edge)

S iz e

10 mm

Flavor

Imprint Code

325MG;L40 3

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 536 -116 4-0 1

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 1/16 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt343

0 1/16 /20 19

Labeler -

Rugby Laboratories (079246066)

Revised: 3/2019

Similar products

Search alerts related to this product

View documents history

Share this information