FDA Label for Dr Simi Pain Reliever Pm

Drug Facts

Active ingredients (in each caplet)

• Acetaminophen 500 mg
• Diphenhydramine HCl 25 mg

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.

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 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).

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

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.

[email protected]

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