safetynadol

safetynadol
SPL v3
SPL
SPL Set ID b956d527-7ea7-e084-e053-2a95a90a866d
Route
oral
Published
Effective Date 2021-01-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (500 mg)
Inactive Ingredients
povidone k30 starch, corn stearic acid sodium starch glycolate type a mannitol sucralose low-substituted hydroxypropyl cellulose, unspecified silicon dioxide magnesium stearate polyethylene glycol 6000 hypromellose 2910 (6 mpa.s) titanium dioxide

Identifiers & Packaging

Pill Appearance
Shape: oval Color: yellow Size: 19 mm Score: 1
Marketing Status
otc monograph drug active Since 2021-01-21

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 500mg


Medication Information

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:











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

Purpose

Pain reliever/fever reducer

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

Description

Acetaminophen 500mg

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

Drug Facts

Package Labeling:

Ask A Doctor Before Use

if you have liver disease

Questions Or Comments ?

x-xxx-xxx-xxxx

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.

Activeingredient(ineachtablet)

Acetaminophen 500mg

If Pregnant Or Breast Feeding,

ask a health professional before use.

Ask A Doctor Or A Pharmacist Before Use

if you are taking blood thinning drug warfarin

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.


Structured Label Content

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:











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

Purpose

Pain reliever/fever reducer

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 (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

Do Not Use (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

Drug Facts

Package Labeling:

Ask A Doctor Before Use (Ask a doctor before use)

if you have liver disease

Questions Or Comments ? (Questions or comments ?)

x-xxx-xxx-xxxx

Stop Use and Ask A Doctor If (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.

Activeingredient(ineachtablet) (ActiveIngredient(Ineachtablet))

Acetaminophen 500mg

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Ask A Doctor Or A Pharmacist Before Use (Ask a doctor or a pharmacist before use)

if you are taking blood thinning drug warfarin

Keep Out of Reach of Children. Overdose Warning: (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.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)