VITAPIRENA- acetaminophen granule, for solution

Vitapirena by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active ingredient & Purposes

• Active ingredient (in each packet): Purposes
• Acetaminophen 500 mg: Pain reliever/ fever reducer

Uses

For the temporary relief of minor aches and pains associated with

• sore throat
• headache
• the common cold/ flu
• muscular aches
• backache
• minor pain from arthritis
• and to reduce fever

Warnings

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

• adult takes more than 8 packets in 24 hours, which is the maximum daily amount for this

product

• child takes more than 5 packets in 24 hours
• with other drugs containing acetaminophen
• adult has 3 or more alcoholic drinks everyday while using this 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

• do not take more than directed

• Age: Dose
• adults and children 12 years of age and over: take one (1) packet, every 4 hours. Do not exceed; adults 8 packets or children 5 packets in 24 hours
• children under 12 years of age: do not use

Other information

• each 5g packet contains: 1 78 mg sodium
• store at room temprature 77-86° F (25-30° C)

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

INGREDIENTS AND APPEARANCE

VITAPIRENA 
acetaminophen granule, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-012
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	LEMON (+Chamomile)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55758-012-05	5 in 1 BOX	10/25/2023
1		1 in 1 PACKET; 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	10/25/2023

Labeler - Pharmadel LLC (030129680)