ANTIGRIP COUGH AND COLD- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl tablet, effervescent 
Pharmadel LLC

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Antigrip Cough and Cold 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:

Warnings

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

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

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

Antigrip Cough and cold

ANTIGRIP  COUGH AND COLD
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl tablet, effervescent
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-502
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorgrayScoreno score
ShapeROUNDSize24mm
FlavorGRAPEImprint Code V3
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55758-502-7236 in 1 CARTON11/01/2024
12 in 1 POUCH; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01211/01/2024
Labeler - Pharmadel LLC (030129680)

Revised: 10/2024
Document Id: 25a23e5e-302d-7b7f-e063-6294a90a0463
Set id: 25a23e5e-302a-7b7f-e063-6294a90a0463
Version: 1
Effective Time: 20241029
 
Pharmadel LLC