Dr Simi Pain Reliever PM
Acetaminophen, Diphenhydramine Hydrochloride · Tablet, Coated · Oral
Active ingredient
Drug Facts Active ingredients (in each caplet) Acetaminophen 500 mg Diphenhydramine HCl 25 mg
Purpose
Purpose Acetaminophen 500 mg Pain reliever Diphenhydramine HCl 25 mg Nighttime sleep aid
Uses
Uses temporary 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 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.
Do not use
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
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
Ask a doctor or pharmacist before use if you are ■ taking the blood thinning drug warfarin ■ taking sedatives or tranquilizers
When using this product
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
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.
Pregnancy or breast-feeding
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
Directions ■ do not take more than directed (see overdose warning) adults and children 12 years and over ■ take 2 caplets at bedtime ■ do not take more than 2 caplets of this product in 24 hours children under 12 years ■ do not use
Inactive ingredients
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?
Questions or comments? 855-280-1079
Label text from the FDA structured product label by Farmacias De Similares TX LLC (revised Apr 10, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Acetaminophen in 2 products
- Diphenhydramine Hydrochloride in 1 product
- Diphenhydramine Hcl in 1 product
Dr Simi Pain Reliever PM NDC products (2)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 85786-101 | Acetaminophen 500 mg/1; Diphenhydramine Hydrochloride 25 mg/1 Tablet, Coated | Farmacias De Similares TX LLC | OTC MONOGRAPH DRUG |
| 85786-108 | Diphenhydramine Hcl 25 mg/1; Acetaminophen 500 mg/1 Tablet | Farmacias De Similares TX LLC | OTC MONOGRAPH DRUG |
Frequently asked questions
What is Dr Simi Pain Reliever PM used for?
Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Who makes Dr Simi Pain Reliever PM?
Dr Simi Pain Reliever PM is listed by 1 labeler in the FDA NDC directory, including Farmacias De Similares TX LLC.