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NDC 36800-0459-34 topcare nite time cold and flu relief 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL Details

topcare nite time cold and flu relief 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL

topcare nite time cold and flu relief is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE.

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: 36800-0459-34
Last Updated: 11/30/2022
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: 36800-0459-34
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: 36800-0459-34
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Doxylamine

Product Information

NDC	36800-0459
Product ID	36800-459_ac9b1579-65bc-49a7-8f62-f667b22d3859
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	topcare nite time cold and flu relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	650; 30; 12.5
Active Ingredient Units	mg/30mL; mg/30mL; mg/30mL
Substance Name	ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Labeler Name	Topco Associates LLC
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 36800-0459-34 (36800045934)

Pricing Information	N/A
NDC Package Code	36800-459-34
Billing NDC	36800045934
Package	237 mL in 1 BOTTLE (36800-459-34)
Marketing Start Date	2012-07-11
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f868e4a0-e9fb-4e6a-9984-29a218246241 Details

Active ingredients (in each 30 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses

: temporarily relieves common cold/flu symptoms:
•: cough due to minor throat and bronchial irritation
•: sore throat
•: headache
•: minor aches and pains
•: fever
•: runny nose and sneezing

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

•: more than 4,000 mg of acetaminophen in 24 hours
•: with other drugs containing acetaminophen
•: 3 or more alcoholic drinks every day while using this product

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.
•: 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.
•: if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

•: taking sedatives or tranquilizers
•: taking the blood thinning drug warfarin

When using this product

•: excitability may occur, especially in children
•: marked drowsiness may occur
•: avoid alcoholic drinks
•: be careful when driving a motor vehicle or operating machinery
•: alcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if

•: pain or cough gets worse or lasts more than 7 days
•: fever gets worse or lasts more than 3 days
•: redness or swelling is present
•: new symptoms occur
•: 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.

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.

Directions

•: take only as directed – see Overdose warning
•: only use the dose cup provided
•: do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over	30 mL every 6 hrs
children 4 to under 12 yrs	ask a doctor
children under 4 yrs	do not use

Other information

•: each 30 mL contains: sodium 39 mg
•: store at 20-25°C (68-77°F)

Inactive ingredients

alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions?

1-888-423-0139

Package/Label Principal Display Panel

TopCare® health

COMPARE TO VICKS® NYQUIL® ACTIVE INGREDIENTS

MULTI-SYMPTOM RELIEF

Nite Time Cold & Flu Relief

PAIN RELIEVER-FEVER REDUCER – ACETAMINOPHEN

COUGH SUPPRESSANT – DEXTROMETHORPHAN HBr

ANTIHISTAMINE – DOXYLAMINE SUCCINATE

• Headache, Fever, Sore Throat, Minor Aches & Pains

• Sneezing, Runny Nose

• Cough

ALCOHOL 10%

12 FL OZ (355 mL)

CHERRY FLAVOR

INGREDIENTS AND APPEARANCE

TOPCARE NITE TIME COLD AND FLU RELIEF

acetaminophen, dextromethorphan hbr, doxylamine succinate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-459
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	12.5 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)

Product Characteristics
Color	RED (Clear/Dark Red)	Score
Shape		Size
Flavor	CHERRY (Menthol Aroma)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:36800-459-30	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/19/2011	11/16/2013
2	NDC:36800-459-38	296 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2011	10/18/2013
3	NDC:36800-459-34	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/11/2012
4	NDC:36800-459-40	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/10/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	08/19/2011

Labeler - Topco Associates LLC (006935977)

Revised: 9/2022

Document Id: ac9b1579-65bc-49a7-8f62-f667b22d3859

Set id: f868e4a0-e9fb-4e6a-9984-29a218246241

Version: 9

Effective Time: 20220914