Drug Facts
Active ingredients (in each caplet)
- Acetaminophen 500 mg
- Diphenhydramine HCl 25 mg
Dr Simi Pain Reliever Pm Tablet, Coated
FDA Label NDC 85786-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Farmacias De Similares Tx Llc for the product Dr Simi Pain Reliever Pm (NDC 85786-101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, pupose, uses, warnings, do not use, ask a doctor before use if you have, ask your doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Pupose
- Pain reliever
- Nighttime sleep aid
Uses
Temporarily relief of occasional headaches and minor aches and pains with accompanying sleeplessness.
Warnings
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take.
- More than 2 caplets in 24 hours, which is the maximum daily amount for this product.
- With other drugs containing acetaminophen.
- 3 or more alcoholicdrinks everyday while using this product.
- Skin reddening
- Blisters
- Rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Do Not Use
- With any other drug containing acetaminophen (prescription or not prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- With any other product containing diphenhydramine, even one used on skin.
- In children under 12 years of age.
- 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.
- Trouble urinating due to an enlarged prostate gland.
- Glaucoma.
Ask Your Doctor Or Pharmacist Before Use If You Are
- Taking the blood thinning drug warfarin
- Taking sedative or tranquilizers.
When Using This Product
- Drowsiness will occur
- Avoid alcoholic drinks
- Do not drive a motor vehicle or operate machinery.
Stop Use And Ask A Doctor If
- Sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
- Pain gets worse or lasts more than 10 days.
- Fever gets worse or lasts more than 3 days.
- Redness or swelling is present.
- New symptoms occur.
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.
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 use more than directed (see overdose warning).
- Take 2 caplets at bedtime.
- Do not take more than 2 caplets of this product in 24 hours.
| Adults and children 12 years and over | |
| Children under 12 years | Do not use |
Other Information
- Store at 25 °C (77°F) excursions permitted between 15-30°C (59-86°F)
- Read all product information before using.
- TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Inactive Ingredients
FD&C Blue No. 1, FD&C Blue No. 2, Hypromellose, Magnesium stearate, Microcrystalline cellulose, Polyethylene glycol, Povidone, Pregelatinized starch, Purified water, Stearic Acid, Titanium dioxide.
Questions Or Comments?
(855)-280-1079
Other
Distributed by: FARMACIAS DE SIMILARES TX, LLC
800 Brazos St Ste 260, Austin, TX,
78701, USA.
www.drsimi.com
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Package Label.Principal Display Panel
DR SIMI
NDC 85786-101-90
Extra Strength
Pain Reliver PM
Acetaminophen 500 mg
Pain Reliever
Diphenhydramine HCl 25 mg
Nightime Sleep Aid
100 Caplets
Aspirin Free
Non-Habit Forming
For Adults
* Please review the disclaimer below.
