PAIN AND FEVER- acetaminophen tablet, 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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Rugby Pain & Fever (Acetaminophen 500 mg) Captabs

Drug Facts

Active ingredient (in each captab)

Acetaminophen 500 mg

Purpose

Pain reliever/Fever reducer

Uses

temporarily reduces fever and relieves minor aches and pains caused by
headache
muscular aches
common cold
toothache
backache
premenstrual and menstrual cramps
minor pain of arthritis

Warnings

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

more than 4,000 mg 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
redness or swelling is present
fever gets worse or lasts more than 3 days
new symptoms appear

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 every 6 hours while symptoms last
do not take more than 6 captabs 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 hypromellose, polyethylene glycol, povidone, pregelatinized corn 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

www.rugbylaboratories.com

Rugby®
NDC 0536-3218-01
EXTRA STRENGTH
Pain & Fever

Acetaminophen 500 mg each
100 CAPTABS
Rugby 3218 - APAP 500 mg Caplets

PAIN AND FEVER
acetaminophen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0536-3218
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
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYPROMELLOSES (UNII: 3NXW29V3WO)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE (Capsule shaped Tablet)	Size	17mm
Flavor		Imprint Code	GPI;A5
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0536-3218-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/23/2011	01/31/2020
2	NDC:0536-3218-10	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/23/2011	01/31/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	02/23/2011	01/31/2020

Labeler - RUGBY LABORATORIES (079246066)

Revised: 8/2018

Document Id: 72df4170-b62d-748f-e053-2991aa0a1ff7

Set id: 84e01baf-36dc-493e-886c-292562be14f1

Version: 3

Effective Time: 20180807

RUGBY LABORATORIES