Acetaminophen by Rugby Laboratories ACETAMINOPHEN tablet

Acetaminophen by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active ingredient (in each tablet)

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

minor pain of arthritis

premenstrual and menstrual cramps

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 INGREDIENT

Povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions or comments?

Call 1-800-645-2158

SPL UNCLASSIFIED SECTION

This is a bulk package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*Rugby Laboratories is not affiliated with the owner of the registered trademark Tylenol®.

Distributed by: Rugby Laboratories

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152 USA

www.rugbylaboratories.com

Re-order No. 370596

PRINCIPAL DISPLAY PANEL

Rugby

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

COMPARE TO THE ACTIVE INGREDIENT IN EXTRA STRENGTH TYLENOL®*

NDC: 0536-1172-10

See New Warnings Information & Directions

Extra Strength Acetaminophen

Pain Reliever/Fever Reducer

Aspirin Free

1000 Tablets 500mg each

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1172
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND	Size	12mm
Flavor		Imprint Code	54;27
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1172-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2018
2	NDC: 0536-1172-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	10/01/2018

Labeler - Rugby Laboratories (079246066)