SOHMED PAIN RELIEF PM- acetaminophen and diphenhydramine hydrochloride tablet 
SOHM Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SohMed™ Pain Relief PM

Drug Facts

Active ingredients (in each caplet)Purpose
Acetaminophen 500 mgPain reliever
Diphenhydramine HCl 25 mgNighttime 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 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.

Directions

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 yearsdo 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.

Other information

Inactive ingredients

carnauba wax, FD&C blue #1 aluminium lake, FD&C blue #2 aluminium lake, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium citrate, sodium starch glycolate, titanium dioxide

Contains No Aspirin

Question or comments?

1(856) 2863646

Distributed by : Sohm, Inc.
6920 Knott Ave., Suit A-C
Buena Park, CA 90621

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
SOHMED PAIN RELIEF PM 
acetaminophen and diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50405-007
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen500 mg
Diphenhydramine Hydrochloride (Diphenhydramine) Diphenhydramine Hydrochloride25 mg
Inactive Ingredients
Ingredient NameStrength
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 
Product Characteristics
ColorBLUEScore2 pieces
ShapeOVALSize18mm
FlavorImprint Code CRX
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50405-007-241 in 1 CARTON
124 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34308/25/2013
Labeler - SOHM Inc. (009303848)

Revised: 8/2013
Document Id: e8334d2f-c39d-46e5-adf6-74ec49c0c2fa
Set id: b8bb76c7-fdbc-4db5-aa68-32c41e2a594e
Version: 1
Effective Time: 20130822
 
SOHM Inc.