(DA) Tabcin Red Effervescent (V)

Tabcin by

Drug Labeling and Warnings

Tabcin by is a Otc medication manufactured, distributed, or labeled by Pharmadel LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TABCIN EXTRA STRENGTH- acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet, effervescent 
Pharmadel LLC

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(DA) Tabcin Red Effervescent (V)

Drug Facts

Active ingredients & Purposes

• Active ingredients (in each tablet): Purposes
• Acetaminophen 325 mg...................:

  Pain reliever/ fever reducer

• Chlorpheniramine maleate 2 mg ...........: Antihistamine
• Phenylephrine HCl 5 mg .....................: Nasal decongestant

Uses

For the temporary relief of symptoms due to the common cold/ flu:

• runny nose
• sneezing
• nasal congestion
• minor aches and pain
• headache
• and temporarily reduces fever

Warnings

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

• more than 12 tablets in 24 hours, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Sore throat warning: If sore throat is severe, persists for more than 2 days, and is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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 prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask your doctor or pharmacist before taking this product

Ask a doctor before use if you have

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• glaucoma
• a breathing problem such as emphysema or chronic bronchitis
• difficulty in urination due to enlargement of the 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

• do not exceed the recommended dosage
• may cause drowsiness
• may cause excitability, especially in children
• avoid alcoholic beverages while taking this product
• use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occurs
• pain or nasal congestion persists for more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur

If pregnant or breastfeeding,

ask a health professional before use.

Keep out of reach of children.

In case of an accidental overdose, get medical help or contact a Poison Control 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 of age and older: take two (2) tablets fully dissolved in a 4 oz glass of water every 4 hours. Do not exceed 12 tablets in 24 hours or as directed by a doctor.

■ children under 12 years of age: ask a doctor

Other information

• each tablet contains: potassium 10mg, sodium 246mg
• store in a cool dry place
• protect from sunlight

Inactive ingredients

acesulfame potassium, anhydrous citric acid, FD&C red #40, polysorbate 80, povidone k-30, simethicone, sodium benzoate, sodium bicarbonate, strawberry flavor, sucralose, water.

Questions & comments?

1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com

Dist. by:

Pharmadel LLC.

New Castle, DE 19720

Principle Display Panel

TABCIN  EXTRA STRENGTH
acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet, effervescent

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-408
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
WATER (UNII: 059QF0KO0R)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SUCRALOSE (UNII: 96K6UQ3ZD4)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
DIMETHICONE (UNII: 92RU3N3Y1O)

Product Characteristics
Color	pink	Score	score with uneven pieces
Shape	ROUND	Size	23mm
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55758-408-36	36 in 1 CARTON	06/30/2024	06/30/2024
1		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	06/30/2024	06/30/2024

Labeler - Pharmadel LLC (030129680)

Revised: 10/2024

Document Id: 25b2c5be-8542-bc4a-e063-6394a90ab107

34390-5

Set id: 1ad172fb-d4b2-e28c-e063-6294a90a751f

Version: 2

Effective Time: 20241030