Indications and uses
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
Diabetic Tussin Nighttime Cold and Flu
- Manufacturer
- MEDTECH PRODUCTS INC | Akorn Operating Company LLC (dba Akorn)
- Effective date
- 2022-03-03
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-05-31 23:48:35
Label at a glance#
ProductDiabetic Tussin Nighttime Cold and Flu
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections
Dosage and administration
take every 4 to 6 hours do not exceed more than 6 doses in 24 hours for adults and children over 12 years of age Adults 10 mL (2 teaspoons) Children under 12 years ask a doctor
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredients (in each 10 mL)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Diphenhydramine HCl 25 mg
Purposes
Pain Relief
Cough Suppressant
Antihistamine
Uses
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
Warnings
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.
Do not use
Ask a doctor before use if you have
- 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
Ask a doctor or pharmacist before use
if the user is taking the blood thinning drug warfarin, tranquilizers or sedatives.
When using this product:
- 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
Stop use and ask a doctor if
- redness or swelling is present
- fever gets worse or lasts more than 3 days
- new symptoms occur
- pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
- cough comes back or occurs with rash or headache that lasts
These could be signs of a serious condition.
If pregnant or breast-feeding,
ask a health professional before use.
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 even if you do not notice any signs or symptoms.
Directions
- take every 4 to 6 hours
- do not exceed more than 6 doses in 24 hours for adults and children over 12 years of age
| Adults | 10 mL (2 teaspoons) |
| Children under 12 years | ask a doctor |
Other information
- Store at room temperature 20-25°C (68-77°F)
Inactive ingredients
Acesulfame potassium, artificial raspberry flavor, hypromellose, menthol, methylparaben, polyethylene glycol, potassium sorbate, propylene glycol, purified water, and sucralose. Citric acid may be used to adjust pH.
Questions or comments?
Call: 1-800-579-8327, serious side effects associated with use of this product may be reported to this number.
Package/Label Principal Display Panel
SUGAR & ALCOHOL FREE!
Specifically Formulated for Diabetics
Diabetic Tussin®
NIGHTTIME
COLD & FLU
Acetaminophen (Pain Relief)
Dextromethorphan HBr (Cough Suppressant)
Diphenhydramine HCl (Antihistamine)
Relieves:
- Cough
- Sore throat
- Runny nose & sneezing
- Minor aches & pains
- Headache
- Fever
Improved Berry Flavor
4 FL OZ (118 mL)
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1094131 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution | PSN | 3 |
| 1094131 | acetaminophen 65 MG/ML / dextromethorphan hydrobromide 2 MG/ML / diphenhydramine hydrochloride 2.5 MG/ML Oral Solution | SCD | 3 |
| 1094131 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / diphenhydramine hydrochloride 12.5 MG per 5 ML Oral Solution | SY | 3 |
| 1094131 | APAP 65 MG/ML / Dextromethorphan Hydrobromide 2 MG/ML / Diphenhydramine Hydrochloride 2.5 MG/ML Oral Solution | SY | 3 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61787-516-04 | 2024-07-30 | C162847 | 48780-1 | 1030e365-59fd-111a-e063-dadaa90a10e2 | Diabetic Tussin Nighttime Cold and Flu 61787-516 |
| 61787-516-04 | 2024-01-30 | C162847 | 48780-1 | 1030e365-59fd-111a-e063-dadaa90a10e2 | Diabetic Tussin Nighttime Cold and Flu 61787-516 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61787-516-04 | Diabetic Tussin Nighttime Cold and Flu | 118 mL in 1 BOTTLE | LIQUID | 118 | 3 | |
| 61787-516-04 | Diabetic Tussin Nighttime Cold and Flu | 1 in 1 CARTON | LIQUID | 1 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61787-516 | DIABETIC TUSSIN NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND DIPHENHYDRAMINE HCL) LIQUID [MEDTECH PRODUCTS INC] | 3 | Legacy NDC, 2 package rows | 20220303_4d5e317f-0e32-4cdc-b56e-b792efa972f5.zip |
Products#
Every source-derived product name is available through these pages.
- Diabetic Tussin Nighttime Cold and Flu
- Acetaminophen, Dextromethorphan HBr, and Diphenhydramine HCl
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
- ACESULFAME POTASSIUM
- HYPROMELLOSE, UNSPECIFIED
- MENTHOL, UNSPECIFIED FORM
- METHYLPARABEN
- POLYETHYLENE GLYCOL 400
- POTASSIUM SORBATE
- PROPYLENE GLYCOL
- RASPBERRY
- WATER
- ANHYDROUS CITRIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 61787-516 | 61787-516-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 3f09d224-c1f3-43fc-a177-c3d4d84ae725 | 4d5e317f-0e32-4cdc-b56e-b792efa972f5 | 2022-03-03 | Warnings | 3f09d224-c1f3-43fc-a177-c3d4d84ae725 4d5e317f-0e32-4cdc-b56e-b792efa972f5 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.