Topcare

Diphenhydramine HCl · Cream · Topical, Oral

Over the counter Corticosteroid Histamine-1 Receptor Antagonist Aminoglycoside Antibacterial 1 recall

Active ingredient

Active ingredients (in each 5 mL) Purposes Acetaminophen 160 mg Pain reliever/fever reducer Chlorpheniramine maleate 1 mg Antihistamine Dextromethorphan HBr 5 mg Cough suppressant

Purpose

Active ingredients (in each 5 mL) Purposes Acetaminophen 160 mg Pain reliever/fever reducer Chlorpheniramine maleate 1 mg Antihistamine Dextromethorphan HBr 5 mg Cough suppressant

Uses

Uses temporarily relieves the following cold/flu symptoms: minor aches and pains headache sore throat sneezing and runny nose cough temporarily reduces fever

Warnings

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. to make a child sleepy 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. if your child has ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if your child has liver disease a breathing problem such as chronic bronchitis glaucoma persistent or chronic cough such as occurs with asthma cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product do not exceed recommended dose (see overdose warning ) marked drowsiness may occur sedatives and tranquilizers may increase drowsiness 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) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Do not use

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. to make a child sleepy 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. if your child has ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use

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

Ask a doctor or pharmacist

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

When using this product

When using this product do not exceed recommended dose (see overdose warning ) marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children

Stop use and ask a doctor

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

Keep out of reach of children.

Directions

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 using mL = milliliter find the right dose on chart below. If possible, use weight to dose; otherwise, use age. remove the child protective cap and squeeze your child's dose into the dosing cup repeat dose every 4 hours, while symptoms last do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (mL) under 36 under 4 years do not use 36-47 4 to 5 years do not use unless directed by a doctor 48-95 6 to 11 years 10 mL Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information

Other information each 5 mL contains: sodium 3 mg store at room temperature TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING

Inactive ingredients

Inactive ingredients citric acid, carboxymethylcellulose sodium, D&C Red No. 33, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, flavors, glycerin, microcrystalline cellulose, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

Questions?

Questions or comments? 1-866-467-2748

Label text from the FDA structured product label by Topco Associates, LLC (revised Nov 11, 2025). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Topcare NDC products (13)

NDCStrength & formLabelerType
36800-018Hydrocortisone 1 g/100g
Ointment		Topco Associates LLCOTC MONOGRAPH DRUG
36800-051Hydrocortisone 1 g/100g
Cream		Topco Associates LLCOTC MONOGRAPH DRUG
36800-056Bacitracin Zinc 500 [iU]/g; Neomycin Sulfate 3.5 mg/g; Polymyxin B Sulfate 10000 [iU]/g; Pramoxine Hydrochloride 10 mg/g
Ointment		Topco Associates LLCOTC MONOGRAPH DRUG
36800-089Bacitracin Zinc 500 [iU]/g
Ointment		Topco Associates LLCOTC MONOGRAPH DRUG
36800-099Hydrocortisone 1 g/100g
Cream		Topco Associates LLCOTC MONOGRAPH DRUG
36800-381Neomycin Sulfate 3.5 mg/g; Polymyxin B Sulfate 10000 [iU]/g; Pramoxine Hydrochloride 10 mg/g
Cream		Topco Associates LLCOTC MONOGRAPH DRUG
36800-443Benzocaine 20 g/100g
Liquid		Topco Associates LLCOTC MONOGRAPH DRUG
36800-495Clotrimazole 10 mg/g
Cream		Topco Associates LLCOTC MONOGRAPH DRUG
36800-661Bismuth Subsalicylate 525 mg/30mL
Suspension		TOPCO ASSOCIATES LLCOTC MONOGRAPH DRUG
36800-600Phenol 1.4 g/100mL
Spray		TOPCO ASSOCIATES, LLCOTC MONOGRAPH DRUG
76162-201Diphenhydramine Hydrochloride 12.5 mg/1
Tablet, Chewable		Topco Associates, LLCOTC MONOGRAPH DRUG
76162-559
Kit		Topco Associates, LLCOTC MONOGRAPH DRUG
76162-792Chlorpheniramine Maleate 1 mg/5mL; Dextromethorphan Hydrobromide 5 mg/5mL; Acetaminophen 160 mg/5mL
Suspension		Topco Associates, LLCOTC MONOGRAPH DRUG

Topcare recalls

Frequently asked questions

What is Topcare used for?

Uses temporarily relieves the following cold/flu symptoms: minor aches and pains headache sore throat sneezing and runny nose cough temporarily reduces fever

Who makes Topcare?

Topcare is listed by 4 labelers in the FDA NDC directory, including Topco Associates LLC, TOPCO ASSOCIATES LLC, TOPCO ASSOCIATES, LLC, Topco Associates, LLC.

Has Topcare been recalled?

The FDA enforcement database lists 1 recall for Topcare, most recently D-0158-2021 (class ii): Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.