PAIN AND FEVER- 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.

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Rugby Pain & Fever (Acetaminophen 500 mg) Tablet

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 500 mg

Purposes

Pain reliever/fever reducer

Uses temporarily reduces fever and relieves minor aches and pains caused by

headache
muscular aches
common cold
toothache
premenstrual and menstrual cramps
backache
minor pain of arthritis

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.
if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if you have liver disease

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Stop use and ask a doctor if

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 tablets every 6 hours while symptoms last
do not take more than 6 tablets in 24 hours unless directed by a doctor
do not take for more than 10 days unless directed by a doctor

children under 12 years: ask a doctor

Other information store at room temperature

Inactive ingredients Povidone, pregelatinized starch, sodium starch glycolate, stearic acid

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

TAMPER EVIDENT: 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 USA

www.rugbylaboratories.com

Rugby®

NDC 0536-3231-01

See New Warnings Information & Directions

EXTRA STRENGTH
Pain & Fever

Acetaminophen 500 mg Each

100 TABLETS

Rugby 3231 - APAP 500 mg Tabs

PAIN AND FEVER
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0536-3231
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Ingredient Name	Strength
Inactive Ingredients
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND (flat faced beveled edge)	Size	12mm
Flavor		Imprint Code	GPI;A5
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0536-3231-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/23/2011	06/30/2021
2	NDC:0536-3231-10	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/23/2011	02/28/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	02/23/2011	06/30/2021

Labeler - RUGBY LABORATORIES (079246066)

Revised: 1/2019

Document Id: 7f6b7829-ee0d-7c66-e053-2a91aa0a8f13

Set id: 9fb360d6-dcb6-407a-9dad-1175a6be5255

Version: 3

Effective Time: 20190114

RUGBY LABORATORIES