Principal Display Panel - 118 Ml Bottle Carton
e4ed38cf-fa57-4469-98b7-624277138508
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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Source: dailymed · Ingested: 2026-02-15T12:02:16.573156 · Updated: 2026-02-15T12:02:16.520175