SOHMED SINUS- acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet

SohMed Sinus by

Drug Labeling and Warnings

SohMed Sinus by is a Otc medication manufactured, distributed, or labeled by Sohm Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each caplet)	purpose
Acetaminophen 325 mg	Pain reliever
Guaifenesin 200mg	Expectorant
Phenylephrine HCL 5mg	Nasal decongestant

Uses

• for the temporary relief of :
  • sinus congestion and pressure
  • headache
  • nasal congestion
  • minor aches and pains
  • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive
• temporarily relieves nasal congestion due to the common cold, and hay fever and other upper respiratory allergies

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

• more than 8 caplets in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day 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
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product
• 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
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

When using this product do not exceed recommended dosage

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• pain nasal congestion or cough gets worse or lasts for more than 7 days
• fever gets worse or lasts for more than 3 days
• redness or swelling is present
• new symptoms occur
• cough comes back or occurs with rash or headache that lasts.

  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 PoisonControl Center right away. Prompt 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 1-2 caplets every 4 hours as needed
  • do not take more than 8 caplets in 24 hours
• children under 12 years
  • consult a doctor

Other information

• avoid excessive heat and humidity store between 15°-30°C (59°-86°f)
• See end flap for expiration date and lot number

Inactive ingredients

Colloidal silicon dioxide, sodium lauryl sulphate, edetate disodium, dioctyl sodium sulphosuccinate, polyvinyl pyrollidone, gelatin, corn starch, magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000, sodium benzoate, sodium starch glycolate, stearic acid, purified talc, titanium dioxide

Question or comments?

1(856) 2863646

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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 Tylenol®Sinus Congestion
& Pain Severe Day Time

SEVERE
Sinus Congestion & Pain Relief

Acetaminophen 325 mg, Guaifenesin 200 mg,
Phenylephrine HCl 5 mg

Relieves Sinus Pressure, Nasal Congestion and Fever

24 Caplets

Daytime
Non-Drowsy

INGREDIENTS AND APPEARANCE

SOHMED SINUS 
acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50405-009
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	325 mg
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	200 mg
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	5 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DI-2-HEXYL SODIUM SULFOSUCCINATE (UNII: 772Y8KZU65)
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE K90 (UNII: RDH86HJV5Z)
GELATIN (UNII: 2G86QN327L)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	OVAL	Size	18mm
Flavor		Imprint Code	CRX
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50405-009-24	1 in 1 CARTON
1		24 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	08/25/2013

Labeler - Sohm Inc. (009303848)