SAFETYNADOL- acetaminophen tablet, coated

SafeTynadol by

Drug Labeling and Warnings

SafeTynadol by is a Otc medication manufactured, distributed, or labeled by Sinew Pharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ActiveIngredient(Ineachtablet)

Acetaminophen 500mg

Purpose

Pain reliever/fever reducer

Uses

￭Temporarily relieves minor aches and pains due to: ￭the common cold ￭headache ￭backache ￭minor pain of arthritis ￭muscular aches ￭toothache ￭premenstrual and menstrual cramps ￭Temporarily reduces feverr

Warnings

This products 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 alcohol drinks every day while using this product 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. Liver warning:Allergy alert:

Do not use

￭with any other drug captaining 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

Ask a doctor or a pharmacist before use

if you are taking blood thinning drug warfarin

Stop use and ask a doctor if

￭pain gets worse or last more than 10 days ￭new symptoms occur ￭fever gets worse or lasts more than 3 days ￭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 over dose, 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 use for more than 10 days unless directed by a doctor
• Children under 12 years: Ask a doctor

Other Information

Store at 20-25 °C (66-77 °F)

Inactive ingredients

Pregelatinized Starch, polyvinylpyrrolidone K-30, Corn starch, Stearic acid, Sodium Starch Glycolate, Mannitol, Sucralose, Low Substituted Hydroxyproply Cellulose, light anhydrous silicic acid, Magnesium stearate, PEG 6000, Hydroxypropyl methylcellulose 6cps, Titanium dioxide, Sicopharm yellow 10, Sicopharm red 30

Questions or comments ?

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Package Labeling:

INGREDIENTS AND APPEARANCE

SAFETYNADOL 
acetaminophen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81389-001
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
POVIDONE K30 (UNII: U725QWY32X)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
MANNITOL (UNII: 3OWL53L36A)
SUCRALOSE (UNII: 96K6UQ3ZD4)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 2165RE0K14)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	yellow	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81389-001-01	200 in 1 BOTTLE; Type 0: Not a Combination Product	01/21/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	01/21/2021

Labeler - Sinew Pharma Inc. (656182232)