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Acetaminophen, Dextromethorphan Hbr, Diphenhydramine Hcl

OTC RxCUI 2693770
Contents

Overview

Label date
2026-05-28

Indications and usage

Uses temporarily reduces fever and relieves these common cold/flu symptoms: minor aches and pains headache cough due to minor throat and bronchial irritation sore throat runny nose sneezing controls the impulse to cough to help your child get to sleep

Uses temporarily reduces fever and relieves these common cold/flu symptoms: minor aches & pains headache cough due to minor throat and bronchial irritation sore throat controls the impulse to cough to help your child get to sleep

Purpose

s Pain reliever/fever reducer Antihistamine/Cough Suppressant

s Pain reliever/fever reducer Cough Suppressant

Dosage and administration

Directions this product does not contain directions or complete warnings for adult use do not give more than directed (see Overdose warning) SHAKE WELL BEFORE EACH USE for accurate dosing, use measuring cup provided. Do not use with any other dosing device. children 6 to under 12 years of age: 10 mL in dosing cup provided every 4 hours while symptoms last, do not give more than 5 times in 24 hours children under 6 years of age: do not use unless directed by a doctor

Directions this product does not contain directions or complete warnings for adult use do not give more than directed (see Overdose warning) SHAKE WELL BEFORE EACH USE find right dose on chart below for accurate dosing, use measuring cup provided. Do not use with any other dosing device. give dose every 4 hours while symptoms last do not give more than 5 times in 24 hours children 6 to under 12 years 10 mL every 4 hours children 4 to under 6 years 7.5 mL every 4 hours children under 4 years do not use

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes more than 5 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 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. 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. with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if the child has liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem such as chronic bronchitis persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus). Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product do not use more than directed marked drowsiness may occur sedatives and tranquilizers may increase the drowsiness effect excitability may occur, especially in children Stop use and ask a doctor if pain or cough gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition. Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical even if you do not notice any signs or symptoms.

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes more than 5 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 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. 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. in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use if the child has liver disease cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus). Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin When using this product do not use more than directed Stop use and ask a doctor if pain or cough gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. 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 even if you do not notice any signs or symptoms.

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. with any other product containing diphenhydramine, even one used on skin

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if

Ask a doctor before use if the child has liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem such as chronic bronchitis persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus).

Ask a doctor before use if the child has liver disease cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus).

Ask a doctor or pharmacist before use if

Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin taking sedatives or tranquilizers

Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin

When using this product

this product do not use more than directed marked drowsiness may occur sedatives and tranquilizers may increase the drowsiness effect excitability may occur, especially in children

this product do not use more than directed

Stop use and ask a doctor if

and ask a doctor if pain or cough gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition.

and ask a doctor if pain or cough gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

Overdosage

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical even if you do not notice any signs or symptoms.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical even if you do not notice any signs or symptoms.

Active ingredient (label)

s (in each 10 mL) Acetaminophen 325 mg Diphenhydramine HCl 12.5 mg

s (in each 10 mL) Acetaminophen 320 mg Dextromethorphan HBr, USP 5 mg

Inactive ingredients

s agave syrup (organic), blueberry flavor (organic), flavors (natural), purified water

s agave syrup (organic), blueberry flavor (organic), flavors (natural), purified water

Storage and handling

Other information store between 20-25°C (68-77°F) do not refrigerate

Other information store between 20-25°C (68-77°F) do not refrigerate

Keep out of reach of children

of children.

of children.