VITAPIRENA- acetaminophen granule, for solution 
Pharmadel LLC

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Vitapirina Acetaminophen (APP)

Drug Facts

Active ingredient & Purposes

Active ingredient (in each packet)Purposes
Acetaminophen 500 mgPain reliever/ fever reducer

Uses

For the temporary relief of minor aches and pains associated with

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if:

product

Sore throat warning: If sore throat is severe, persists for more than 2 days, 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 allergic to acetaminophen or any other of the inactive ingredients in this product

Ask a doctor before use if the user

  • has liver disease
  • is a child with pain from arthritis

Ask a doctor or pharmacist before use if the user is

  • taking the blood thinning drug warfarin

Stop use and ask a doctor if

  • adult’s pain gets worse or lasts more than 10 days
  • child’s pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • any new symptoms appear

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

AgeDose
adults and children 12 years of age and overtake one (1) packet, every 4 hours. Do not exceed; adults 8 packets or children 5 packets in 24 hours
children under 12 years of agedo not use

Other information

Inactive ingredients

chamomile lemon flavor, citric acid monohydrate, fructose, povidone k30, silicon dioxide, sodium bicarbonate, sucralose, water

Questions?

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

Distributed by:

PHARMADEL LLC.

New Castle, DE 19720

Principal Display Panel

PDP Vitapirena CL

VITAPIRENA 
acetaminophen granule, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-012
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
POVIDONE K30 (UNII: U725QWY32X)  
WATER (UNII: 059QF0KO0R)  
FRUCTOSE (UNII: 6YSS42VSEV)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorLEMON (+Chamomile) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55758-012-055 in 1 BOX10/25/2023
11 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01310/25/2023
Labeler - Pharmadel LLC (030129680)

Revised: 11/2023
Document Id: 09bba642-59c9-c2cd-e063-6394a90a69e6
Set id: 0547bc1f-d000-f5a6-e063-6294a90ac73d
Version: 2
Effective Time: 20231109
 
Pharmadel LLC