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NDC 11673-0719-34 up and up nighttime cough control dm max 30; 12.5 mg/20mL; mg/20mL Details

up and up nighttime cough control dm max 30; 12.5 mg/20mL; mg/20mL

up and up nighttime cough control dm max is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Target Corporation. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE.

MedlinePlus Drug Summary

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: 11673-0719-34
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan

Doxylamine is used in the short-term treatment of insomnia (difficulty falling asleep or staying asleep). Doxylamine is also used in combination with decongestants and other medications to relieve sneezing, runny nose, and nasal congestion caused by the common cold. Doxylamine should not be used to cause sleepiness in children. Doxylamine 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: 11673-0719-34
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Doxylamine

Product Information

NDC	11673-0719
Product ID	11673-719_535f14ed-a8a1-4814-9e40-8d54a5c61680
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	up and up nighttime cough control dm max
Proprietary Name Suffix	n/a
Non-Proprietary Name	Dextromethorphan HBr, Doxylamine succinate
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	30; 12.5
Active Ingredient Units	mg/20mL; mg/20mL
Substance Name	DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Labeler Name	Target Corporation
Pharmaceutical Class	Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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 11673-0719-34 (11673071934)

Pricing Information	N/A
NDC Package Code	11673-719-34
Billing NDC	11673071934
Package	1 BOTTLE in 1 CARTON (11673-719-34) / 237 mL in 1 BOTTLE
Marketing Start Date	2018-09-26
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d610bf3b-b615-4eb5-b124-0bf0ddc58acd Details

Active ingredients (in each 20 mL)

Dextromethorphan HBr, USP 30 mg

Doxylamine succinate, USP 12.5 mg

Purposes

Cough suppressant

Antihistamine

Uses

•: temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
•: temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
•: runny nose
•: sneezing
•: itchy, watery eyes
•: itching of the nose or throat
•: controls the impulse to cough to help you sleep

Warnings

Do not use

•: to make a child sleepy
•: 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.

Ask a doctor before use if you have

•: trouble urinating due to an enlarged prostate gland
•: glaucoma
•: cough that occurs with too much phlegm (mucus)
•: a breathing problem such as emphysema or chronic bronchitis
•: persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

•: do not use more than directed
•: marked drowsiness may occur
•: 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 children

Stop use and ask a doctor if

cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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 (1-800-222-1222).

Directions

•: measure only with dosing cup provided
•: keep dosing cup with product
•: mL = milliliter
•: do not take more than 4 doses in any 24-hour period
•: this adult product is not intended for use in children under 12 years of age

age	dose
adults and children 12 years and over	20 mL every 6 hours
children under 12 years	do not use

Other information

•: each 20 mL contains: sodium 11 mg
•: store at 20-25°C (68-77°F)

Inactive ingredients

anhydrous citric acid, benzoic acid, benzyl alcohol, carboxymethylcellulose sodium, FD&C blue #1, FD&C red #40, flavor, glycerin, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Questions or comments?

1-888-547-7400

Package/Label Principal Display Panel

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Compare to active ingredients in Robitussin® Maximum Strength Nighttime Cough DM

maximum strength

nighttime cough control DM MAX

dextromethorphan HBr (cough suppressant)

doxylamine succinate (antihistamine)

relieves cough, itchy throat and runny nose

for adults

AGES 12 + YEARS

8 FL OZ (237 mL)

INGREDIENTS AND APPEARANCE

UP AND UP NIGHTTIME COUGH CONTROL DM MAX

dextromethorphan hbr, doxylamine succinate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11673-719
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg in 20 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	12.5 mg in 20 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
BENZOIC ACID (UNII: 8SKN0B0MIM)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	FRUIT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11673-719-34	1 in 1 CARTON	09/26/2018
1		237 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	09/26/2018

Labeler - Target Corporation (006961700)

Revised: 12/2019

Document Id: 535f14ed-a8a1-4814-9e40-8d54a5c61680

Set id: d610bf3b-b615-4eb5-b124-0bf0ddc58acd

Version: 2

Effective Time: 20191213