Vitapirina Acetaminophen (v)

Vitapirina Acetaminophen (v)
SPL v3
SPL
SPL Set ID 0547bc1f-d000-f5a6-e063-6294a90ac73d
Route
ORAL
Published
Effective Date 2023-11-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Anhydrous Citric Acid Sodium Bicarbonate Povidone K30 Water Fructose Sucralose Silicon Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-25

Description

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


Medication Information

Description

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
Section 55105-1

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

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

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
Questions?

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

Distributed By:

PHARMADEL LLC.

New Castle, DE 19720

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

Principal Display Panel

Active Ingredient & Purposes

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.

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

Structured Label Content

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
Section 55105-1 (55105-1)

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

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

Do Not Use (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
Questions?

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

Distributed By: (Distributed by:)

PHARMADEL LLC.

New Castle, DE 19720

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

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

Principal Display Panel

Active Ingredient & Purposes (Active ingredient & Purposes)

Stop Use and Ask A Doctor If (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, (If pregnant or breastfeeding,)

ask a health professional before use.

Keep Out of Reach of Children. (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.

Ask A Doctor Before Use If the User (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 (Ask a doctor or pharmacist before use if the user is)
  • taking the blood thinning drug warfarin

Advanced Ingredient Data


Raw Label Data

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