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NDC 41250-0771-22 Cold and Flu Details

Cold and Flu

Cold and Flu is a KIT in the HUMAN OTC DRUG category. It is labeled and distributed by Meijer Distribution Inc. The primary component is .

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: 41250-0771-22
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: 41250-0771-22
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: 41250-0771-22
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Doxylamine

Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.

Related Packages: 41250-0771-22
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine

Product Information

NDC	41250-0771
Product ID	41250-771_64f19a65-dc27-404d-9eb4-4ad3d75a863b
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	Cold and Flu
Proprietary Name Suffix	Daytime, Nighttime
Non-Proprietary Name	Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	KIT
Route	n/a
Active Ingredient Strength	n/a
Active Ingredient Units	n/a
Substance Name	n/a
Labeler Name	Meijer Distribution Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2023-12-31

Package

Package Images

NDC 41250-0771-22 (41250077122)

Pricing Information	N/A
NDC Package Code	41250-771-22
Billing NDC	41250077122
Package	1 KIT in 1 PACKAGE, COMBINATION (41250-771-22) * 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date	2020-06-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL deb10b4d-55bd-4a2c-8f14-4bfe07fab72b Details

Active ingredients (in each liquid-filled capsule) (Daytime Cold & Flu)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Active ingredients (in each liquid-filled capsule) (Nighttime Cold & Flu)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses

temporarily relieves common cold and flu symptoms:
- fever
- headache
- sore throat
- minor aches and pains
- cough due to minor throat and bronchial irritation
- nasal congestion (Daytime only)
- runny nose and sneezing (Nighttime 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

cough that occurs with too much phlegm (mucus)
difficulty in urination due to enlargement of the prostate gland
liver disease
diabetes (Daytime only)
heart disease (Daytime only)
thyroid disease (Daytime only)
high blood pressure (Daytime only)
persistent or chronic cough such as occurs with smoking, asthma, or emphysema (Daytime only)
a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema (Nighttime only)
glaucoma (Nighttime only)

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
marked drowsiness may occur (Nighttime only)
avoid alcoholic beverages (Nighttime only)
excitability may occur, especially in children (Nighttime only)
use caution when driving a motor vehicle or operating machinery (Nighttime only)
alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occur (Daytime only)
pain, nasal congestion, or cough gets worse or lasts more than 7 days (Daytime only)
pain or cough gets worse or lasts more than 7 days (Nighttime only)
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.

In case of accidental 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.

Read each section carefully. 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 8 capsules per 24 hours
adults and children 12 years and over: take 2 capsules with water every 4 hours
children under 12 years: ask a doctor

Directions (Nighttime only)

do not take more than directed
do not take more than 8 capsules per 24 hours
adults and children 12 years and over: take 2 capsules with water every 6 hours
children under 12 years: ask a doctor

Do not take more than 8 capsules of Daytime and Nighttime products in any 24-hour period.

Other information

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
protect from light, heat and moisture
see end flap for expiration date and lot number

Inactive ingredients (Daytime only)

FD&C red #40, FD&C yellow #6, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, white ink

Inactive ingredients (Nighttime only)

D&C yellow #10, FD&C Blue #1, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, white ink

Questions or comments?

1-800-426-9391

Principal display panel

COMBO PACK

Total

48 Softgels

NDC 41250-771-22

meijer® Compare to Vicks® DayQuil® Cold & Flu LiquiCaps® active ingredients* NON-DROWSY MULTI-SYMPTOM daytime cold & flu Acetaminophen Dextromethorphan HBr Phenylephrine HCl Pain Reliever/Fever Reducer Cough Suppressant Nasal Decongestant 32 Softgels Actual Size Relieves: Aches, Fever, Sore Throat, Nasal Congestion, Cough	meijer® Compare to Vicks® NyQuil® Cold & Flu LiquiCaps® active ingredients* MULTI-SYMPTOM nighttime cold & flu Acetaminophen Dextromethorphan HBr Doxylamine Succinate Pain Reliever/Fever Reducer Cough Suppressant Antihistamine 16 Softgels Actual Size Relieves: Aches, Fever, Sore Throat, Sneezing, Runny Nose, Cough

TAMPER EVIDENT: DO NOT USE IF

PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

DIST. BY MEIJER

DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

www.meijer.com

*This product is not manufactured or distributed by The Procter & Gamble Company,

owner of the registered trademark Vicks® DayQuil® and NyQuil® Cold & Flu LiquiCaps®.

50844 ORG012073073122

Product of Dubai

Packaged and Quality Assured in the USA

Meijer 44-730731

INGREDIENTS AND APPEARANCE

COLD AND FLU DAYTIME, NIGHTTIME

acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41250-771

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41250-771-22	1 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product	06/02/2020

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	4 BLISTER PACK	32
Part 2	2 BLISTER PACK	16

Part 1 of 2
COLD AND FLU DAYTIME acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled

Product Information
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	orange (clear red orange)	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	730
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		8 in 1 BLISTER PACK; 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	06/02/2020

Part 2 of 2
COLD AND FLU NIGHTTIME acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filled

Product Information
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg

Ingredient Name	Strength
Inactive Ingredients
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	green	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	731
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		8 in 1 BLISTER PACK; 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	06/02/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	06/02/2020

Labeler - Meijer Distribution Inc (006959555)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(41250-771)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	pack(41250-771)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(41250-771)

Revised: 4/2022

Document Id: 64f19a65-dc27-404d-9eb4-4ad3d75a863b

Set id: deb10b4d-55bd-4a2c-8f14-4bfe07fab72b

Version: 3

Effective Time: 20220407

Search by Drug Name or NDC

NDC 41250-0771-22 Cold and Flu Details

Cold and Flu

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 41250-0771-22 (41250077122)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL deb10b4d-55bd-4a2c-8f14-4bfe07fab72b Details

Active ingredients (in each liquid-filled capsule) (Daytime Cold & Flu)

Purpose

Active ingredients (in each liquid-filled capsule) (Nighttime Cold & Flu)

Purpose

Uses

Warnings

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.

Directions (Daytime only)

Directions (Nighttime only)

Other information

Inactive ingredients (Daytime only)

Inactive ingredients (Nighttime only)

Questions or comments?

Principal display panel

INGREDIENTS AND APPEARANCE

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