Search by Drug Name or NDC

NDC 61787-0516-04 Diabetic Tussin Nighttime Cold and Flu 650; 20; 25 mg/10mL; mg/10mL; mg/10mL Details

Diabetic Tussin Nighttime Cold and Flu 650; 20; 25 mg/10mL; mg/10mL; mg/10mL

Diabetic Tussin Nighttime Cold and Flu is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by MEDTECH PRODUCTS INC. The primary component is ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DIPHENHYDRAMINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Related Packages: 61787-0516-04
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen

Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.

Related Packages: 61787-0516-04
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dextromethorphan

Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Related Packages: 61787-0516-04
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine

Product Information

NDC	61787-0516
Product ID	61787-516_3f09d224-c1f3-43fc-a177-c3d4d84ae725
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Diabetic Tussin Nighttime Cold and Flu
Proprietary Name Suffix	n/a
Non-Proprietary Name	Acetaminophen, Dextromethorphan HBr, and Diphenhydramine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	650; 20; 25
Active Ingredient Units	mg/10mL; mg/10mL; mg/10mL
Substance Name	ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DIPHENHYDRAMINE HYDROCHLORIDE
Labeler Name	MEDTECH PRODUCTS INC
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 61787-0516-04 (61787051604)

Pricing Information	N/A
NDC Package Code	61787-516-04
Billing NDC	61787051604
Package	1 BOTTLE in 1 CARTON (61787-516-04) / 118 mL in 1 BOTTLE
Marketing Start Date	2020-02-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4d5e317f-0e32-4cdc-b56e-b792efa972f5 Details

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)

INGREDIENTS AND APPEARANCE

DIABETIC TUSSIN NIGHTTIME COLD AND FLU

acetaminophen, dextromethorphan hbr, and diphenhydramine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61787-516
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg in 10 mL
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg in 10 mL

Ingredient Name	Strength
Inactive Ingredients
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
RASPBERRY (UNII: 4N14V5R27W)
WATER (UNII: 059QF0KO0R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Product Characteristics
Color		Score
Shape		Size
Flavor	RASPBERRY (artificial raspberry flavor)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:61787-516-04	1 in 1 CARTON	02/01/2020
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	02/01/2020

Labeler - MEDTECH PRODUCTS INC (114707784)

Name	Address	ID/FEI	Business Operations
Establishment
Akorn Operating Company LLC (dba Akorn)		117696873	manufacture(61787-516)

Revised: 3/2022

Document Id: 3f09d224-c1f3-43fc-a177-c3d4d84ae725

Set id: 4d5e317f-0e32-4cdc-b56e-b792efa972f5

Version: 3

Effective Time: 20220303