Antigrip Daytime Tea C-h (as)

Antigrip Daytime Tea C-h (as)
SPL v2
SPL
SPL Set ID 12f20aba-f991-bd82-e063-6294a90a4aac
Route
ORAL
Published
Effective Date 2024-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (200 mg) Acetaminophen (325 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg)
Inactive Ingredients
Anhydrous Citric Acid Silicon Dioxide Isopropyl Alcohol Maltodextrin Water Acesulfame Aspartame Sodium Citrate Sucrose Tribasic Calcium Phosphate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-28

Description

Active ingredients (in each packet) Purposes Acetaminophen 325 mg………………………………… Pain reliever/ fever reducer Dextromethorphan HBr 10 mg…………………………... Cough suppressant Guaifenesin 200 mg ..................................... Expectorant Phenylephrine HCL 5 mg…….………………………….. Nasal decongestant


Medication Information

Description

Active ingredients (in each packet) Purposes Acetaminophen 325 mg………………………………… Pain reliever/ fever reducer Dextromethorphan HBr 10 mg…………………………... Cough suppressant Guaifenesin 200 mg ..................................... Expectorant Phenylephrine HCL 5 mg…….………………………….. Nasal decongestant

Uses

Temporary relieves common cold/flu symptoms:

  • minor aches and pains
  • sore throat
  • headache
  • stuffy nose
  • nasal congestion
  • cough due to minor throat and bronchial irritation
  • and temporarily reduces fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
Section 55105-1
Active ingredients (in each packet) Purposes
Acetaminophen 325 mg………………………………… Pain reliever/ fever reducer
Dextromethorphan HBr 10 mg…………………………... Cough suppressant

Guaifenesin 200 mg .....................................

Expectorant

Phenylephrine HCL 5 mg…….…………………………..

Nasal decongestant

Warnings

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

  • more than 6 packets 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

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.

Dist. By:

PHARMADEL LLC

New Castle, DE, 19720

Directions
  • dissolve one packet in an 8oz. glass of hot water. If using a microwave; add content into a glass of cool water and stir briskly before and after heating. Do not overheat.
  • sip while hot and consume the entire drink within 10-15 minutes

Age Dose
adults and children 12 years of age and over one (1) packet every 4 hours,

take every 4 hours; do not exceed 6 packets in a 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 you are now taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product
Other Information
  • each packet contains: potassium 10 mg, sodium 27 mg
  • phenylketonurics: contains phenylalanine 13 mg per packet
  • store at room temperature 68-77°F (20-25°C)
  • do not use if packet is punctured or torn
Inactive Ingredients

acesulfame potassium, anhydrous citric acid, aspartame, chamomile honey flavors, isopropyl alcohol, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate, water

Questions & Comments?

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

Principal Display Panel

When Using This Product
  • do not exceed recommended dosage
Stop Use and Ask Doctor If
  • nervousness, dizziness, or sleeplessness occurs
  • redness or swelling is present
  • pain or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • any new symptoms occur
  • a persistent cough or symptoms do not improve within 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

If Pregnant Or Breast Feeding,

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 You Have
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • a cough that is accompanied by excessive phlegm (mucus)
  • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • difficulty urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
  • taking the blood thinning drug warfarin

Structured Label Content

Uses

Temporary relieves common cold/flu symptoms:

  • minor aches and pains
  • sore throat
  • headache
  • stuffy nose
  • nasal congestion
  • cough due to minor throat and bronchial irritation
  • and temporarily reduces fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
Section 55105-1 (55105-1)
Active ingredients (in each packet) Purposes
Acetaminophen 325 mg………………………………… Pain reliever/ fever reducer
Dextromethorphan HBr 10 mg…………………………... Cough suppressant

Guaifenesin 200 mg .....................................

Expectorant

Phenylephrine HCL 5 mg…….…………………………..

Nasal decongestant

Warnings

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

  • more than 6 packets 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

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.

Dist. By: (Dist. by:)

PHARMADEL LLC

New Castle, DE, 19720

Directions
  • dissolve one packet in an 8oz. glass of hot water. If using a microwave; add content into a glass of cool water and stir briskly before and after heating. Do not overheat.
  • sip while hot and consume the entire drink within 10-15 minutes

Age Dose
adults and children 12 years of age and over one (1) packet every 4 hours,

take every 4 hours; do not exceed 6 packets in a 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 you are now taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product
Other Information (Other information)
  • each packet contains: potassium 10 mg, sodium 27 mg
  • phenylketonurics: contains phenylalanine 13 mg per packet
  • store at room temperature 68-77°F (20-25°C)
  • do not use if packet is punctured or torn
Inactive Ingredients (Inactive ingredients)

acesulfame potassium, anhydrous citric acid, aspartame, chamomile honey flavors, isopropyl alcohol, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate, water

Questions & Comments? (Questions & comments?)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

When Using This Product (When using this product)
  • do not exceed recommended dosage
Stop Use and Ask Doctor If (Stop use and ask doctor if)
  • nervousness, dizziness, or sleeplessness occurs
  • redness or swelling is present
  • pain or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • any new symptoms occur
  • a persistent cough or symptoms do not improve within 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

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 You Have (Ask a doctor before use if you have)
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • a cough that is accompanied by excessive phlegm (mucus)
  • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • difficulty urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking the blood thinning drug warfarin

Advanced Ingredient Data


Raw Label Data

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