COLD AND FLU PLUS CONGESTION NIGHTTIME- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl solution

Cold and Flu plus Congestion by

Drug Labeling and Warnings

Cold and Flu plus Congestion by is a Otc medication manufactured, distributed, or labeled by WALMART INC., LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 30 mL)

Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Doxylamine succinate 12.5 mg
Phenylephrine HCl 10 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant

Uses

• temporarily relieves common cold and flu symptoms:
  • runny nose and sneezing
  • nasal congestion
  • sore throat
  • headache
  • minor aches and pains
  • cough to help you sleep
  • sinus congestion and pressure
  • cough due to minor throat and bronchial irritation
• temporarily reduces fever
• reduces swelling of nasal passages
• temporarily restores freer breathing through the nose
• promotes nasal and/or sinus drainage

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

• difficulty in urination due to enlargement of the prostate gland
• 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
• glaucoma
• heart disease
• high blood pressure
• liver disease
• thyroid disease
• diabetes

Ask a doctor or pharmacist before use if you are

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

When using this product

• do not exceed recommended dosage
• excitability may occur, especially in children
• avoid alcoholic beverages
• marked drowsiness may occur
• alcohol, sedatives, and tranquilizers may increase drowsiness
• use caution when driving a motor vehicle or operating machinery

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
• 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 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.

Directions

• do not take more than directed
• mL = milliliter
• only use the dose cup provided
• do not exceed 4 doses per 24 hours
• adults and children 12 years and over: 30 mL every 4 hours
• children under 12 years: do not use

Other information

• each 30 mL contains: sodium 11 mg
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• use by expiration date on package

Inactive ingredients

anhydrous citric acid, D&C yellow #10, FD&C blue #1, flavors, glycerin, polyethylene glycol 400, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sodium saccharin, sorbitol, sucralose

Questions or comments?

1-888-287-1915

Principal display panel

equate™                                   NDC: 79903-191-12

Compare to Vicks® NYQuil®
VapoCOOL® Severe
Cold & Flu + Congestion
active ingredients*

NIGHTTIME     SEVERE

VAPOR CHILLING 

COLD & FLU
+ CONGESTION

ACETAMINOPHEN-
Pain Reliever/ Fever Reducer
Dextromethorphan HBr-
Cough Suppressant
Doxylamine Succinate- Antihistamine
Phenylephrine HCl-
Nasal Decongestant

Relieves:

• Headache, fever, sore throat, minor aches & pains
• Nasal congestion, sinus pressure
• Sneezing, runny nose
• Cough

For Ages 12+

12 FL OZ (355 mL)                                    F-060
                                                                   ORG

 

TAMPER EVIDENT: DO NOT USE IF PRINTED
NECK WRAP IS BROKEN OR MISSING

DISTRUBUTED BY: Walmart Inc., Bentoville, AR 72716
*This product is not manufactured or
distributed by The Procter & Gamble
Company, owner of the registered
trademark Vicks® NyQuil® VapoCOOL®
SEVERE COLD & FLU + CONGESTION.

50844     ORG062306002

Equate 44-060

INGREDIENTS AND APPEARANCE

COLD AND FLU PLUS CONGESTION  NIGHTTIME
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79903-191
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	12.5 mg  in 30 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	green (bluish)	Score
Shape		Size
Flavor	MINT (eucalyptus)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79903-191-12	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/16/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	08/16/2023

Labeler - WALMART INC. (051957769)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	manufacture(79903-191) , pack(79903-191)