Drug Facts Active Ingredients (In Each Caplet)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Dr. Simi Pain Reliever Pm Tablet
FDA Label NDC 85786-108
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 85786-108). 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 active ingredients (in each caplet), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a 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
Purpose
| Acetaminophen 500 mg | Pain reliever |
Diphenhydramine HCl 25 mg | Nighttime sleep aid |
Uses
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Warnings
Liver warning: This product contains 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 alcoholic drinks every day while using this product
Allergy alert: 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.
Do Not Use
■ with any other drug containing acetaminophen (prescription or nonprescription). 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
■ glaucoma
■ a breathing problem such as emphysema or chronic bronchitis
■ trouble urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
■ taking the blood thinning drug warfarin
■ taking sedatives 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.
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 take more than directed (see overdose warning)
| adults and children 12 years and over | ■ take 2 caplets at bedtime
|
| children under 12 years | ■ do not use |
Other Information
■ store between 20-25°C (68-77°F) in a dry place
■ retain carton for complete product information
Inactive Ingredients
colloidal silicon dioxide, copovidone, croscarmellose sodium, FD&C blue #1, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide
Questions Or Comments?
855-280-1079
Principal Display Panel
NDC: 85786-108-24
DR. SIMI
Extra strength
Pain Reliever PM
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Pain Reliever / Nighttime Sleep Aid
For Adults
24 Caplets
†Compare to the active ingredients in Tylenol® PM Extra Strength Caplets
†This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Tylenol® PM Extra Strength Caplets.
DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROJEN OR MISSING
Distributed by:
FARMACIAS DE SIMILARES TX LLC
800 Brazos St Ste 260, Austin, TX, 78701, USA
[email protected]
www.drsimi.com
* Please review the disclaimer below.
