(DA)Tabcin Purple 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 COUGH AND COLD- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl tablet, effervescent 
Pharmadel LLC

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(DA)Tabcin Purple 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
• Dextromethorphan HBr 10 mg ...........: Cough suppressant
• Phenylephrine HCl 5 mg .....................: Nasal decongestant

Uses

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

• runny nose
• sneezing
• nasal congestion
• cough due to minor throat and bronchial irritation
• minor aches and pain
• headache
• sore throat
• 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

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.

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 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 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
• a persistent or chronic cough such as occurs with smoking, asthma, or emphysema
• a cough is accompanied by excessive phlegm (mucus)

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 marked drowsiness
• may cause excitability, especially in children
• may cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect
• 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, cough, or nasal congestion gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• cough comes back or occurs with a rash or headache that lasts. These could be signs of a serious condition.

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: do not use

Other information

• each tablet contains: potassium 10mg, sodium 290mg
• store below 77° F (25° C) and in a dry place

Inactive ingredients

acesulfame potassium, anhydrous citric acid, FD&C blue #1, FD&C red #40, grape flavor, polysorbate 80, povidone k-30, simethicone, sodium benzoate, sodium bicarbonate, sucralose, water

Questions or 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

PRINCIPAL DISPLAY PANEL

TABCIN  COUGH AND COLD
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl tablet, effervescent

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-446
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
SUCRALOSE (UNII: 96K6UQ3ZD4)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
DIMETHICONE (UNII: 92RU3N3Y1O)

Product Characteristics
Color	gray	Score	no score
Shape	ROUND	Size	24mm
Flavor	GRAPE	Imprint Code	V3
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55758-446-36	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: 25a0f3d4-81f3-a013-e063-6394a90a8a77

34390-5

Set id: 201f1a11-876d-bc6f-e063-6394a90aa918

Version: 3

Effective Time: 20241029