DailyMed - COLD AND FLU DAYTIME NIGHTTIME- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl, triprolidine hcl kit

NDC Code(s): 11673-779-96, 11673-885-45, 11673-889-45
Packager: Target Corporation

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: OTC monograph final

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.

Drug Label Information

Updated February 3, 2023

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Active ingredients (in each 20 mL) (Daytime Cold & Flu)

Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCl 10 mg
Purpose

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
Active ingredients (in each 20 mL) (Nighttime Severe Cold & Flu)

Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Phenylephrine HCl 10 mg
Triprolidine HCl 2.5 mg
Purpose

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Antihistamine
Uses
- temporarily relieves these common cold and flu symptoms:
  - sore throat
  - nasal congestion
  - stuffy nose
  - minor aches and pains
  - sneezing (Nighttime only)
  - headache
  - cough
  - runny nose (Nighttime only)
  - itching of the nose or throat (Nighttime only)
  - itchy, watery eyes due to hay fever (Nighttime only)
  - sinus congestion and pressure
- temporarily reduces fever
- controls cough to help you get to sleep
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (Daytime only)
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
- diabetes
- thyroid disease
- heart disease
- glaucoma (Nighttime only)
- difficulty in urination due to enlargement of the prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
- high blood pressure
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers (Nighttime only)
When using this product
- do not exceed recommended dosage
- excitability may occur, especially in children (Nighttime only)
- marked drowsiness may occur (Nighttime only)
- alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
- avoid alcoholic beverages (Nighttime only)
- use caution when driving a motor vehicle or operating machinery (Nighttime only)
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, or cough gets worse or lasts more than 7 days
- new symptoms occur
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- 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 for adults as well as for children even if you do not notice any signs or symptoms.

Do not take DAYTIME and NIGHTTIME products at the same time.
Directions (Daytime only)
- do not take more than directed
- do not take more than 6 doses in any 24-hour period
- mL = milliliter; FL OZ = fluid ounce
- only use the dose cup provided
- adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours
- children under 12 years: do not use
Directions (Nighttime only)
- do not take more than directed
- do not take more than 4 doses in any 24-hour period
- mL = milliliter; FL OZ = fluid ounce
- only use the dose cup provided
- adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours
- children under 12 years: do not use
Other information
- each 20 mL contains: sodium 10 mg (Daytime only)
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- use by expiration date on package
Inactive ingredients (Daytime only)

anhydrous citric acid, disodium edetate, FD&C blue #1, FD&C red #40, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sorbitol, sucralose, xanthan gum
Inactive ingredients (Nighttime only)

anhydrous citric acid, FD&C blue #1, FD&C red #40, FD&C yellow #6, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum
Questions?

Call 1-800-910-6874

Principal display panel

Compare to active ingredients in Maximum
Strength Mucinex®Fast-Max®Cold & Flu*

daytime
cold and flu

acetaminophen
(pain reliever/fever reducer)
dextromethorphan HBr (cough suppressant)
guaifenesin (expectorant)
phenylephrine HCl (nasal decongestant)

minor aches and pains, fever,
nasal congestion and sinus pressure,
sore throat, cough, chest congestion

up & up™

MAX STRENGTH

AGES
12+
YEARS

NDC 11673-779-96
Compare to active ingredients in Maximum
Strength Mucinex® Nightshift® Severe Cold & Flu*

nighttime severe
cold and flu

acetaminophen
(pain reliever/fever reducer)
dextromethorphan HBr
(cough suppressant)
phenylephrine HCl (nasal decongestant)
triprolidine HCl (antihistamine)

minor aches and pains, fever,
nasal congestion, sore throat, sneezing,
itchy throat, runny nose, cough

up & up™

MAX
STRENGTH

AGES
12+
YEARS

TOTAL 12 FL OZ (355 mL) - 2 x 6 FL OZ (177 mL) EACH

TAMPER EVIDENT: DO NOT
USE IF IMPRINTED SAFETY
SEAL UNDER CAP IS
BROKEN OR MISSING

PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org

Do Not Take Daytime
and Nighttime Products
at the Same Time.

094 14 0185 R01 C-001744-01-067
Distributed by Target Corporation
Minneapolis, MN 55403
TM & ©2022 Target Brands, Inc.

*This product is not manufactured or distributed by RB Health (US)
LLC, owner of the registered trademark Maximum Strength
Mucinex® Fast-Max® Cold & Flu and Maximum Strength Mucinex®
Nightshift® Severe Cold & Flu. 50844 REV1222A04207845

Target 44-042078

INGREDIENTS AND APPEARANCE

COLD AND FLU DAYTIME NIGHTTIME
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl, triprolidine hcl kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11673-779

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11673-779-96	1 in 1 PACKAGE; Type 0: Not a Combination Product	05/17/2022

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 BOTTLE, PLASTIC	177 mL
Part 2	1 BOTTLE, PLASTIC	177 mL

Part 1 of 2

COLD AND FLU DAYTIME
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solution

Product Information
Item Code (Source)	NDC:11673-885
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg in 20 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg in 20 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor	BERRY (MIXED)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11673-885-45	177 mL in 1 BOTTLE, PLASTIC; 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	05/17/2022

Part 2 of 2

COLD AND FLU NIGHTTIME
acetaminophen, dextromethorphan hbr, phenylephrine hcl, triprolidine hcl solution

Product Information
Item Code (Source)	NDC:11673-889
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg in 20 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg in 20 mL
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM)	TRIPROLIDINE HYDROCHLORIDE	2.5 mg in 20 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor	FRUIT (MIXED)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11673-889-45	177 mL in 1 BOTTLE, PLASTIC; 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	05/17/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	05/17/2022

Labeler - Target Corporation (006961700)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	manufacture(11673-779) , pack(11673-779)

View All Sections

Published Date (What is this?)	Version	Files
Feb 6, 2023	2 (current)	download
May 18, 2022	1	download

	RxCUI	RxNorm NAME	RxTTY
1	1116572	acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution	PSN
2	1116572	acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution	SCD
3	1116572	acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution	SY
4	1116572	acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral Solution	SY
5	1116572	APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution	SY
6	2173662	acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG / triprolidine HCl 2.5 MG in 20 mL Oral Solution	PSN
7	2173662	acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral Solution	SCD
8	2173662	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG / triprolidine hydrochloride 1.25 MG per 10 mL Oral Solution	SY
9	2173662	acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG / triprolidine hydrochloride 2.5 MG per 20 mL Oral Solution	SY
10	2173662	APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML / Triprolidine Hydrochloride 0.125 MG/ML Oral Solution	SY
11	2375931	1 daytime (6 OZ acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG per 10 mL Oral Solution) / 1 nighttime (6 OZ acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG / triprolidine HCl 1.25 MG per 10 mL Oral Solution) Pack	PSN
12	2375931	{1 (180 ML) (acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) / 1 (180 ML) (acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral Solution) } Pack	GPCK
13	2375931	1 daytime (6 OZ acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution) / 1 nighttime (6 OZ acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG / triprolidine HCl 1.25 MG per 10 ML Oral Solution) Pack	SY

Label: COLD AND FLU DAYTIME NIGHTTIME- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl, triprolidine hcl kit

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Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

	NDC
1	11673-779-96
2	11673-885-45
3	11673-889-45

Label: COLD AND FLU DAYTIME NIGHTTIME- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl, triprolidine hcl kit

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

COLD AND FLU DAYTIME NIGHTTIME- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl, triprolidine hcl kit

Number of versions: 2

COLD AND FLU DAYTIME NIGHTTIME- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl, triprolidine hcl kit

COLD AND FLU DAYTIME NIGHTTIME- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl, triprolidine hcl kit

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COLD AND FLU DAYTIME NIGHTTIME- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl, triprolidine hcl kit

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.