Principal Display Panel - 118 Ml Bottle Carton

Principal Display Panel - 118 Ml Bottle Carton
SPL v3
SPL
SPL Set ID e4ed38cf-fa57-4469-98b7-624277138508
Route
ORAL
Published
Effective Date 2023-11-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Drug Facts


Medication Information

Indications and Usage

temporarily relieves these common cold and flu symptoms: minor aches and pains headache nasal congestion sore throat cough runny nose itching of the nose or throat sneezing temporarily reduces fever temporarily restores freer breathing through the nose

Dosage and Administration

do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage. measure only with dosage cup provided keep dosage cup with product mL = milliliter age dose adults and children 12 years and over 20 mL every 4 hours do not take more than 6 doses in any 24-hour period children 6 to 12 years 10 mL every 4 hours do not give more than 5 doses in any 24-hour period children under 6 years do not use

Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

each 10 mL contains: sodium 7 mg and potassium 6 mg store at 20-25°C (68-77°F) read and keep carton

Section 50565-1

Keep out of reach of children. In case of 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

nervousness, dizziness or sleeplessness occurs pain, cough, or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults) fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.

Section 50567-7

do not use more than directed may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children

Section 50568-5

taking the blood thinning drug warfarin taking any other oral nasal decongestant or stimulant taking sedatives or tranquilizers

Section 50569-3

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

Section 50570-1

to sedate a child or to make a child sleepy in a child under 6 years of age 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. with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on skin

Section 51727-6

anhydrous citric acid, artificial flavor, edetate disodium, FD & C red no. 40, glycerin, menthol, polyethylene glycol, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Section 51945-4

CHILDREN'S Dimetapp ® ACETAMINOPHEN (Pain Reliever/Fever Reducer) DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant) PHENYLEPHRINE HCl (Nasal Decongestant) PHARMACIST RECOMMENDED Multi- Symptom Cold & Flu Relieves + comforts: ✓ Fever ✓ Head & body aches ✓ Cough ✓ Stuffy, runny nose ✓ Sneezing ✓ Sore throat 6+ YRS 4 FL OZ (118 mL) Red Grape Flavor • Alcohol Free

Section 53413-1

Call 1-888-594-0828 weekdays 9 AM to 5 PM EST

Section 53414-9

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

Section 55105-1

Active ingredients (in each 10 mL) Purposes Acetaminophen, 320 mg Pain reliever/fever reducer Diphenhydramine HCl, 12.5 mg Antihistamine/cough suppressant Phenylephrine HCl, 5 mg Nasal decongestant


Structured Label Content

Indications and Usage (34067-9)

temporarily relieves these common cold and flu symptoms: minor aches and pains headache nasal congestion sore throat cough runny nose itching of the nose or throat sneezing temporarily reduces fever temporarily restores freer breathing through the nose

Dosage and Administration (34068-7)

do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage. measure only with dosage cup provided keep dosage cup with product mL = milliliter age dose adults and children 12 years and over 20 mL every 4 hours do not take more than 6 doses in any 24-hour period children 6 to 12 years 10 mL every 4 hours do not give more than 5 doses in any 24-hour period children under 6 years do not use

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

each 10 mL contains: sodium 7 mg and potassium 6 mg store at 20-25°C (68-77°F) read and keep carton

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. 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)

nervousness, dizziness or sleeplessness occurs pain, cough, or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults) fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.

Section 50567-7 (50567-7)

do not use more than directed may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful 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 any other oral nasal decongestant or stimulant taking sedatives or tranquilizers

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

to sedate a child or to make a child sleepy in a child under 6 years of age 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. with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on skin

Section 51727-6 (51727-6)

anhydrous citric acid, artificial flavor, edetate disodium, FD & C red no. 40, glycerin, menthol, polyethylene glycol, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Section 51945-4 (51945-4)

CHILDREN'S Dimetapp ® ACETAMINOPHEN (Pain Reliever/Fever Reducer) DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant) PHENYLEPHRINE HCl (Nasal Decongestant) PHARMACIST RECOMMENDED Multi- Symptom Cold & Flu Relieves + comforts: ✓ Fever ✓ Head & body aches ✓ Cough ✓ Stuffy, runny nose ✓ Sneezing ✓ Sore throat 6+ YRS 4 FL OZ (118 mL) Red Grape Flavor • Alcohol Free

Section 53413-1 (53413-1)

Call 1-888-594-0828 weekdays 9 AM to 5 PM EST

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 10 mL) Purposes Acetaminophen, 320 mg Pain reliever/fever reducer Diphenhydramine HCl, 12.5 mg Antihistamine/cough suppressant Phenylephrine HCl, 5 mg Nasal decongestant


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