SohMed Pain Relief PM Acetaminophen and Diphenhydramine Hydrochloride Acetaminophen Acetaminophen Diphenhydramine Hydrochloride Diphenhydramine CARNAUBA WAX FD&C Blue No. 1 FD&C Blue No. 2 aluminum oxide HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL 6000 POLYSORBATE 80 POWDERED CELLULOSE PROPYLENE GLYCOL STARCH, CORN SHELLAC SODIUM CITRATE SODIUM STARCH GLYCOLATE TYPE A CORN TITANIUM DIOXIDE CRX
Drug Facts
Composition & Profile
Identifiers & Packaging
PRINCIPAL DISPLAY PANEL - 24 Caplet Bottle Carton SohMed ™ NDC XXXXXXXXXX *Compare to the active ingredients in Extra Strength Tylenol ® PM Extra Strength Pain Relief PM Acetaminophen 500 mg, Diphenhydramine HCl 25 mg Pain Reliever / Nighttime Sleep aid 24 Caplets Non-Habit Forming Principal Display Panel - 24 Caplet Bottle Carton
- PRINCIPAL DISPLAY PANEL - 24 Caplet Bottle Carton SohMed ™ NDC XXXXXXXXXX *Compare to the active ingredients in Extra Strength Tylenol ® PM Extra Strength Pain Relief PM Acetaminophen 500 mg, Diphenhydramine HCl 25 mg Pain Reliever / Nighttime Sleep aid 24 Caplets Non-Habit Forming Principal Display Panel - 24 Caplet Bottle Carton
Overview
Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Indications & Usage
Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Dosage & Administration
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 this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.
Warnings & Precautions
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 everyday while using this product Although rare, possible reactions to consumption of acetaminophen include three serious skin diseases whose symptoms can include rash, blisters and, in the worst case, widespread damage to the surface of the skin. If you are taking this product and develop a rash or other skin reaction, stop taking this product immediately and seek medical attention. 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 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 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 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 or reach of children. Overdose warning Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Purpose
Active ingredients (in each caplet) Purpose Acetaminophen 500 mg Pain reliever Diphenhydramine HCl 25 mg Nighttime sleep aid
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 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.
When Using
When using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery
Stop Use & Ask a Doctor
Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be 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.
Keep Out of Reach of Children
Keep out or reach of children.
Storage & Handling
Other information Store between 20°-25°C (68°-77°F) See end flap for expiration date and lot number
Questions
Question or comments? 1(856) 2863646
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