RELAGESIC- acetaminophen and phenyltoloxamine citrate tablet
International Ethical Labs.

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.

----------

Relagesic

Drug Facts

Active ingredients (In each tablet)	Purpose
Acetaminophen 500 mg	Pain Reliever
Phenyltoloxamine Citrate 29 mg	Antihistamine

Uses

Temporarily relieves

minor aches and pains
backache
muscle aches
headache
cramps
bloating

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take;
more than 3,000 mg (6 tablets) of acetaminophen in 24 hours;
with other drugs containing acetaminophen;
3 or more alcoholic drinks everyday while using this product
Do not exceed recommended dosage.
In rare cases, acetaminophen may cause a severe skin reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Do not use this product

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 have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

liver disease
a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you the user is taking

sedatives or tranquilizers
taking the blood thinning drug warfarin

When using this product

excitability may occur, especially in children
drowsiness may occur
alcohol, sedatives and tranquilizers may increase drowsiness
avoid alcoholic beverages
use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

new symptoms occur
redness or swelling is present
pain gets worse,or lasts more than 10 days
fever gets worse or lasts more than 3 days

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose Warning

Taking more than the recommended dose may cause liver damage.

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

Do not exceed recommended dosage.

Adults and children 12 years of age and over:	Take 1 tablet every 4-6 hours, not to exceed 6 tablets in 24 hours, or as directed by a doctor.
Children under 12 years of age:	Do not use in children under 12 years of age. This will provide more than the recommended dose (overdose) of acetaminophen and could cause liver damage.

Inactive ingredients

Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate, and Tricalcium Phosphate.

Rev. 10/14

Question? Comments?

Call 1-787-765-3510

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

NDC 11584-477-01

Strong Effective Pain Reliever

Relagesic

100 Tablets

Each tablet contains:
Acetaminophen 500 mg
Phenyltoloxamine Citrate 29 mg

Caffeine Free
Multi-Symptom Relief of Cramps,
Backache, Headache, and Bloating

Principal Display Panel - 100 Tablet Bottle Label

RELAGESIC
acetaminophen and phenyltoloxamine citrate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11584-4770
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
PHENYLTOLOXAMINE CITRATE (UNII: 8UE48MJH8M) (PHENYLTOLOXAMINE - UNII:K65LB6598J)	PHENYLTOLOXAMINE CITRATE	29 mg

Ingredient Name	Strength
Inactive Ingredients
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)

Product Characteristics
Color	white	Score	2 pieces
Shape	OVAL (Capsule shape)	Size	18mm
Flavor		Imprint Code	Relagesic;500
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11584-4770-1	100 in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	02/15/2015	05/31/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	02/15/2015	05/31/2016

Labeler - International Ethical Labs. (091176933)

Revised: 3/2018

Document Id: 6764fe2a-f6e0-9700-e053-2a91aa0a10f1

Set id: 119dce18-5d01-494b-9609-fb8b1607db0c

Version: 2

Effective Time: 20180314

International Ethical Labs.