Antigrip Nighttime Tea G-h-l (as)

Antigrip Nighttime Tea G-h-l (as)
SPL v4
SPL
SPL Set ID 12de30fd-95b6-f16d-e063-6294a90aeba2
Route
ORAL
Published
Effective Date 2024-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Doxylamine (6.25 mg) Acetaminophen (325 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg)
Inactive Ingredients
Anhydrous Citric Acid Isopropyl Alcohol Maltodextrin Water Silicon Dioxide 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 Doxylamine succinate 6.25 mg ..................................... Antihistamine Phenylephrine HCI 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 Doxylamine succinate 6.25 mg ..................................... Antihistamine Phenylephrine HCI 5 mg…….………………………….. Nasal decongestant

Uses

Temporary relieves common cold/flu symptoms:

  • minor aches and pains
  • sore throat
  • headache
  • nasal congestion
  • runny nose
  • itching of nose or throat
  • stuffy nose
  • cough due to minor throat and bronchial irritation
  • and temporarily reduces fever
Section 55105-1
Active ingredients (in each packet) Purposes
Acetaminophen 325 mg………………………………… Pain reliever/ fever reducer
Dextromethorphan HBr 10 mg…………………………... Cough suppressant

Doxylamine succinate 6.25 mg .....................................

Antihistamine

Phenylephrine HCI 5 mg…….…………………………..

Nasal decongestant

Dist By:

PHARMADEL LLC

New Castle, DE 19720

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.

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, isopropyl alcohol, lemon ginger honey flavors, 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
  • may cause excitability, especially in children
  • use caution when driving a motor vehicle or operating machinery
  • may cause marked drowsiness
Stop Use and Ask Doctor If
  • nervousness, dizziness, or sleeplessness occurs
  • redness or swelling is present
  • pain, cough, or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • any new symptoms occur
  • cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

Ask A Doctor Before Use If You
  • have liver disease
  • have heart disease
  • have high blood pressure
  • have thyroid disease
  • have diabetes
  • have glaucoma
  • have a cough that is accompanied by excessive phlegm (mucus)
  • have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • have difficulty urinating due to an enlarged prostate gland
  • are taking sedatives or tranquilizers
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 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
  • nasal congestion
  • runny nose
  • itching of nose or throat
  • stuffy nose
  • cough due to minor throat and bronchial irritation
  • and temporarily reduces fever
Section 55105-1 (55105-1)
Active ingredients (in each packet) Purposes
Acetaminophen 325 mg………………………………… Pain reliever/ fever reducer
Dextromethorphan HBr 10 mg…………………………... Cough suppressant

Doxylamine succinate 6.25 mg .....................................

Antihistamine

Phenylephrine HCI 5 mg…….…………………………..

Nasal decongestant

Dist By: (Dist by:)

PHARMADEL LLC

New Castle, DE 19720

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.

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, isopropyl alcohol, lemon ginger honey flavors, 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
  • may cause excitability, especially in children
  • use caution when driving a motor vehicle or operating machinery
  • may cause marked drowsiness
Stop Use and Ask Doctor If (Stop use and ask doctor if)
  • nervousness, dizziness, or sleeplessness occurs
  • redness or swelling is present
  • pain, cough, or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • any new symptoms occur
  • cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

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