Principal Display Panel

Principal Display Panel
SPL v4
SPL
SPL Set ID 852e5822-9bc0-06ed-e053-2a91aa0a5f1b
Route
ORAL
Published
Effective Date 2020-06-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Active ingredients (in each packet) Purposes Acetaminophen 650 mg……………………………………………………………… Pain reliever/ fever reducer Dextromethorphan HBr 20 mg…………………………………………………………… Cough suppressant Phenylephrine HCI 10 mg…….………………………………..…………………………… Nasal decongestant Chlorpheniramine maleate 4 mg………………………………………………………… Antihistamine


Medication Information

Warnings and Precautions

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 Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. 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.

Indications and Usage

Temporary relieves common cold/flu symptoms: sore throat headache muscular aches backaches minor aches and pains runny nose sneezing itching of the nose or throat stuffy nose itchy, watery eyes due to hay fever or other upper respiratory allergies nasal & sinus congestion cough due to minor throat and bronchial irritation temporarily reduces fever

Dosage and Administration

DO NOT EXCEED RECOMMENDED DOSE take every 4 hours; do not exceed 6 packets in a 24 hour period dissolve the contents of one packet into 8 oz. glass of hot water and sip while hot; consume entire drink within 10-15 minutes if using a microwave; add contents of one packet to 8 oz. glass of cool water, stir briskly before and after heating. Do not overheat. Age Dose adults and children 12 years of age and over one packet every 4 hours children under 12 years of age do not use

Description

Active ingredients (in each packet) Purposes Acetaminophen 650 mg……………………………………………………………… Pain reliever/ fever reducer Dextromethorphan HBr 20 mg…………………………………………………………… Cough suppressant Phenylephrine HCI 10 mg…….………………………………..…………………………… Nasal decongestant Chlorpheniramine maleate 4 mg………………………………………………………… Antihistamine

Section 42229-5

each packet contains: sodium 26.73 mg, potassium 9.71 mg phenylketonurics: contains phenylalanine 13 mg per packet store at room temperature 68-77°F (20-25°C) avoid excessive heat and moisture TAMPER EVIDENT: Do not use if carton or packets are torn or punctured.

Section 50565-1

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.

Section 50566-9

symptoms do not improve new symptoms occur pain or fever persists or gets worse redness or swelling is present nervousness, dizziness, or sleeplessness occurs a persistent cough or symptoms persists for more than 7 days, gets worse, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition.

Section 50567-7

may cause drowsiness; alcohol, sedatives and tranquilizers may increase drowsiness effect avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery excitability may occur, especially in children

Section 50568-5

taking the blood thinning drug warfarin taking sedatives or tranquilizers

Section 50569-3

liver disease heart disease high blood pressure thyroid disease diabetes glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to enlargement of the prostate gland taking sedatives or tranquilizers a persistent or chronic cough such as occurs with smoking, asthma, or emphysema a cough is accompanied by excessive phlegm (mucus)

Section 50570-1

with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. for more than 7 days for pain or 3 days for fever unless directed by a doctor 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 doctor or pharmacist before taking this product to sedate a child

Section 51727-6

acesulfame potassium, aspartame, citric acid, flavor, isopropyl alcohol, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate, water

Section 51945-4

NDC 55758-313-18 ANTIGRIP® Nighttime Cold & Cough

Section 53413-1

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

Section 53414-9

ask a health professional before use.

Section 55105-1

Active ingredients (in each packet) Purposes Acetaminophen 650 mg……………………………………………………………… Pain reliever/ fever reducer Dextromethorphan HBr 20 mg…………………………………………………………… Cough suppressant Phenylephrine HCI 10 mg…….………………………………..…………………………… Nasal decongestant Chlorpheniramine maleate 4 mg………………………………………………………… Antihistamine


Structured Label Content

Indications and Usage (34067-9)

Temporary relieves common cold/flu symptoms: sore throat headache muscular aches backaches minor aches and pains runny nose sneezing itching of the nose or throat stuffy nose itchy, watery eyes due to hay fever or other upper respiratory allergies nasal & sinus congestion cough due to minor throat and bronchial irritation temporarily reduces fever

Dosage and Administration (34068-7)

DO NOT EXCEED RECOMMENDED DOSE take every 4 hours; do not exceed 6 packets in a 24 hour period dissolve the contents of one packet into 8 oz. glass of hot water and sip while hot; consume entire drink within 10-15 minutes if using a microwave; add contents of one packet to 8 oz. glass of cool water, stir briskly before and after heating. Do not overheat. Age Dose adults and children 12 years of age and over one packet every 4 hours children under 12 years of age do not use

Warnings and Precautions (34071-1)

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 Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. 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.

Section 42229-5 (42229-5)

each packet contains: sodium 26.73 mg, potassium 9.71 mg phenylketonurics: contains phenylalanine 13 mg per packet store at room temperature 68-77°F (20-25°C) avoid excessive heat and moisture TAMPER EVIDENT: Do not use if carton or packets are torn or punctured.

Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

symptoms do not improve new symptoms occur pain or fever persists or gets worse redness or swelling is present nervousness, dizziness, or sleeplessness occurs a persistent cough or symptoms persists for more than 7 days, gets worse, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition.

Section 50567-7 (50567-7)

may cause drowsiness; alcohol, sedatives and tranquilizers may increase drowsiness effect avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery excitability may occur, especially in children

Section 50568-5 (50568-5)

taking the blood thinning drug warfarin taking sedatives or tranquilizers

Section 50569-3 (50569-3)

liver disease heart disease high blood pressure thyroid disease diabetes glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to enlargement of the prostate gland taking sedatives or tranquilizers a persistent or chronic cough such as occurs with smoking, asthma, or emphysema a cough is accompanied by excessive phlegm (mucus)

Section 50570-1 (50570-1)

with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. for more than 7 days for pain or 3 days for fever unless directed by a doctor 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 doctor or pharmacist before taking this product to sedate a child

Section 51727-6 (51727-6)

acesulfame potassium, aspartame, citric acid, flavor, isopropyl alcohol, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate, water

Section 51945-4 (51945-4)

NDC 55758-313-18 ANTIGRIP® Nighttime Cold & Cough

Section 53413-1 (53413-1)

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

Section 53414-9 (53414-9)

ask a health professional before use.

Section 55105-1 (55105-1)

Active ingredients (in each packet) Purposes Acetaminophen 650 mg……………………………………………………………… Pain reliever/ fever reducer Dextromethorphan HBr 20 mg…………………………………………………………… Cough suppressant Phenylephrine HCI 10 mg…….………………………………..…………………………… Nasal decongestant Chlorpheniramine maleate 4 mg………………………………………………………… Antihistamine


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