Indications and 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
SafeTynadol
- Manufacturer
- Sinew Pharma Inc.
- Effective date
- 2023-10-28
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-05-31 23:58:18
Label at a glance#
ProductSafeTynadol
Active ingredientACETAMINOPHEN
Label structure8 sections
Dosage and administration
￭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
Storage and handling
Store at 20-25 °C (66-77 °F)
Contacts and useful links#
Label contents#
Full prescribing information#
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 ?
x-xxx-xxx-xxxx
Package Labeling:
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 81389-001-01 | SafeTynadol | 200 in 1 BOTTLE | TABLET, COATED | 200 | 3 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- SafeTynadol
- ACETAMINOPHEN
- 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
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 81389-001 | 81389-001-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| SafeTynadol | ACETAMINOPHEN | Sinew Pharma Inc. | b956d527-7ea7-e084-e053-2a95a90a866d | 2023-10-28 | Warnings | 81389-001-01 81389-001 81389000101 08c11030-7b99-55ae-e063-6394a90a1437 b956d527-7ea7-e084-e053-2a95a90a866d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.