Principal Display Panel Ck Cold, 6ct

Principal Display Panel Ck Cold, 6ct
SPL v7
SPL
SPL Set ID 661b94d6-871a-4312-8d31-994558f15ee7
Route
ORAL
Published
Effective Date 2021-03-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Drug Facts


Medication Information

Indications and Usage

for the temporary relief of the following cold/flu symptoms: minor aches and pains headache sore throat nasal congestion cough impulse to cough helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily reduces fever

Dosage and Administration

adults and children 12 years and over take 2 tablets with water every 6-8 hours as needed do not take more than 8 tablets in 24 hours, or as directed by a doctor children under 12 years of age ask a doctor

Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

store at room temperature 59-86° F (15-30° C)

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) 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

pain, nasal congestion or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or is accompanied by a fever, rash or persistent headache nervousness, dizziness, or sleeplessness occur. These could be signs of a serious condition.

Section 50567-7

do not exceed recommended dosage

Section 50568-5

taking the blood thinning drug warfarin

Section 50569-3

liver disease heart disease diabetes thyroid disease high blood pressure trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema

Section 50570-1

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 a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 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.

Section 51727-6

maltodextrin, microcrystalline cellulose, povidone, silicon dioxide may contain , sodium starch glycolate, starch, stearic acid

Section 51945-4

CIRCLE K ® Cold severe congestion Acetaminophen, Dextromethorphan HBr, Guaifenesin and Phenylephrine HCl Pain Reliever/Fever Reducer, Cough Suppressant, Expectorant, Nasal Decongestant ACTUAL SIZE Non-Drowsy Relief of - Nasal Congestion - Sore Throat - Cough, Impulse to Cough 4 Tablets 2 POUCHES, 2 TABLETS PER POUCH

Section 53413-1

call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Active ingredients (in each tablet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 15 mg Cough suppressant Guaifenesin 200 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant


Structured Label Content

Indications and Usage (34067-9)

for the temporary relief of the following cold/flu symptoms: minor aches and pains headache sore throat nasal congestion cough impulse to cough helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily reduces fever

Dosage and Administration (34068-7)

adults and children 12 years and over take 2 tablets with water every 6-8 hours as needed do not take more than 8 tablets in 24 hours, or as directed by a doctor children under 12 years of age ask a doctor

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

store at room temperature 59-86° F (15-30° C)

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) 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)

pain, nasal congestion or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or is accompanied by a fever, rash or persistent headache nervousness, dizziness, or sleeplessness occur. These could be signs of a serious condition.

Section 50567-7 (50567-7)

do not exceed recommended dosage

Section 50568-5 (50568-5)

taking the blood thinning drug warfarin

Section 50569-3 (50569-3)

liver disease heart disease diabetes thyroid disease high blood pressure trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema

Section 50570-1 (50570-1)

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 a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 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.

Section 51727-6 (51727-6)

maltodextrin, microcrystalline cellulose, povidone, silicon dioxide may contain , sodium starch glycolate, starch, stearic acid

Section 51945-4 (51945-4)

CIRCLE K ® Cold severe congestion Acetaminophen, Dextromethorphan HBr, Guaifenesin and Phenylephrine HCl Pain Reliever/Fever Reducer, Cough Suppressant, Expectorant, Nasal Decongestant ACTUAL SIZE Non-Drowsy Relief of - Nasal Congestion - Sore Throat - Cough, Impulse to Cough 4 Tablets 2 POUCHES, 2 TABLETS PER POUCH

Section 53413-1 (53413-1)

call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Active ingredients (in each tablet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 15 mg Cough suppressant Guaifenesin 200 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant


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