Diabetic Tussin Nighttime Cold and Flu
Dosage form: liquid
Ingredients: ACETAMINOPHEN 325mg in 5mL, DEXTROMETHORPHAN HYDROBROMIDE 10mg in 5mL, DIPHENHYDRAMINE HYDROCHLORIDE 12.5mg in 5mL
Labeler: Health Care Products
NDC Code: 61787-452
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Diphenhydramine HCl 12.5 mg
Pain Relief
Cough Suppressant
Antihistamine
temporarily relieves common cold/flu symptoms including:
- cough due to minor throat and bronchial irritation
- sore throat
- headache
- minor aches and pains
- muscular aches
- fever
- runny nose and sneezing
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
- adults take more than 6 doses in 24 hours, which is the maximum daily amount
- child takes more than 5 doses in 24 hours, which is the maximum daily amount
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks everyday while using this product
Sore throat warning: If sore throat is severe, persists for more than two days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
- 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.
- with any other product containing diphenhydramine, even one used on the skin
- liver disease
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to enlargement of the prostate gland
- cough that occurs with too much phlegm (mucus)
- a chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
if the user is taking the blood thinning drug warfarin, tranquilizers or sedatives.
- you may get very drowsy
- 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 small children
- redness or swelling is present
- fever gets worse or lasts more than 3 days
- new symptoms occur
- cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts
These could be signs of a serious condition.
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical even if you do not notice any signs or symptoms.
- take every 4 to 6 hours
- do not exceed more than 5 doses in 24 hours for children under 12 years of age
- do not exceed more than 6 doses in 24 hours for adults and children over 12 years of age
| adults & children 12 years & over | 10 mL (2 teaspoonfuls) |
| children 6 years to under 12 years | 5 mL (1 teaspoonful) |
| children under 6 years | ask a doctor |
- Phenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL)
- Store at room temperature 20-25°C (68-77°F)
Acesulfame potassium, aspartame, citric acid, hypromellose, menthol, methylparaben, natural & artificial orange flavor, polyethylene glycol, potassium sorbate, propylene glycol, purified water. Sodium citrate may be used to adjust pH.
Call: 1-800-899-3116, Mon-Thurs 9:00 am - 5:00 pm EST, Fri 9:00 am - 2:30 pm EST.
Serious side effects associated with use of this product may be reported to this number.
Rev. 452:04 12/11
NDC 61787-452-04
Diabetic Tussin®
DECONGESTANT FREE
Nighttime
Cold & Flu
FEVER, HEADACHE
BODY ACHES
COUGHS
SNEEZING
RUNNY NOSE
Liquid
NO
Sodium
Sorbitol
Fructose
& Dyes
ACETAMINOPHEN
DEXTROMETHORPHAN HBr
DIPHENHYDRAMINE HCl
SAFE FOR DIABETICS
SUGAR & ALCOHOL FREE!
GLUTEN FREE
4 FL OZ (118 mL)
| DIABETIC TUSSIN NIGHTTIME COLD AND FLU
acetaminophen, dextromethorphan hbr, and diphenhydramine hcl liquid |
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| Labeler - Health Care Products (101196749) |
| Registrant - Hi-Tech Pharmacal Co., Inc. (101196749) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Hi-Tech Pharmacal Co., Inc. | 101196749 | MANUFACTURE(61787-452) | |
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
