MULTI SYMPTOM SEVERE COLD AND NIGHTTIME SEVERE COLD AND COUGH- acetaminophen, dextromethorphan hbr, diphenhydramine hcl, phenylephrine hcl 
WAL-MART STORES INC

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.

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Wal-Mart Multi- Symptom Severe Cold and Nighttime Severe Cold and Cough Day & Night Value Pack

Active ingredients (in each packet) – Multi Symptom Severe Cold

Acetaminophen 500 mg

Dextromethorphan hydrobromide 20 mg

Phenylephrine hydrochloride 10 mg

Active ingredients (in each packet) - Nighttime Severe Cold and Cough

Acetaminophen 650 mg

Diphenhydramine hydrochloride 25 mg

Phenylephrine hydrochloride 10 mg

Purpose - Multi Symptom Severe Cold

Pain reliever/fever reducer

Cough Suppressant

Nasal Decongestant

Purpose - Nighttime Severe Cold and Cough

Pain reliever/fever reducer

Antihistamine/Cough suppressant

Nasal decongestant

Uses - Multi Symptom Severe Cold

temporarily relieves these symptoms due to a cold:
minor aches and pains
minor sore throat pain
headache
nasal and sinus congestion
cough due to minor throat and bronchial irritation
temporarily reduces fever

Uses - Nighttime Severe Cold and Cough

temporarily relieves these symptoms due to a cold:
minor aches and pains
minor sore throat pain
headache
nasal and sinus congestion
runny nose
sneezing
itchy nose or throat
itchy, watery eyes due to hay fever
cough due to minor throat and bronchial irritation
temporarily reduces fever

Warnings – Multi Symptom Severe Cold /Nighttime Severe Cold and Cough

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 - Multi Symptom Severe Cold

in a child under 12 years of age
if you are allergic to acetaminophen
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a 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.

Do not use - Nighttime Severe Cold and Cough

in a child under 12 years of age
if you are allergic to acetaminophen
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a pharmacist.
with any other product containing diphenhydramine, even one used on skin
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 - Multi Symptom Severe Cold

liver disease
heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland
cough that occurs with too much phlegm (mucus)
cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema

Ask a doctor before use if you have - Nighttime Severe Cold and Cough

liver disease
heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
trouble urinating due to an enlarged prostate gland
a breathing problem such as emphysema or chronic bronchitis
cough that occurs with too much phlegm (mucus)
cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are - Multi Symptom Severe Cold

taking the blood thinning drug warfarin

Ask a doctor or pharmacist before use if you are - Nighttime Severe Cold and Cough

taking sedatives or tranquilizers
taking the blood thinning drug warfarin

When using this product - Multi Symptom Severe Cold

do not exceed recommended dosage

When using this product - Nighttime Severe Cold and Cough

do not exceed recommended dosage
avoid alcoholic drinks
marked drowsiness may occur
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 – Multi Symptom Severe Cold /Nighttime Severe Cold and Cough

nervousness, dizziness, or sleeplessness occurs
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
pain, cough or nasal congestion gets worse or lasts more than 7 days
cough comes back or occurs with fever, 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 (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions – Multi Symptom Severe Cold

do not use more than directed
take every 4 hours, while symptoms persist .do not take more than 6 packets in 24 hours unless directed by a doctor

Age

Dose

Adults and children 12 years of age

One packet

Children under 12 years of age

Do not use

dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10 - 15 minutes.
if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating, Do not overheat

Directions Nighttime Severe Cold and Cough

do not use more than directed
take every 4 hours while symptoms persist, not to exceed 5 packets in 24 hours unless directed by a doctor

Age

Dose

Adults and Children 12 years of age and over

One packet

Children under 12 years of age

do not use

dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10 - 15 minutes.
if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating, Do not overheat.

Other information - Multi Symptom Severe Cold

each packet contains: potassium 6 mg
store at room temperature. Protect from excessive heat and moisture.

Other information - Nighttime Severe Cold and Cough

each packet contains: potassium 6 mg
store at room temperature. Protect from excessive heat and moisture

Inactive ingredients - Multi Symptom Severe Cold

citric acid, caramel, flavors, maltodextrin, potassium chloride, silica, sucralose, sucrose

Inactive ingredients - Nighttime Severe Cold and Cough

citric acid, F D & C yellow #6 , flavors, maltodextrin, potassium chloride, silica ,sucralose, sucrose,

Questions or comments?

1-866-467-2748

Package/Label Principal Display Panel

NDC# 49035-948-12

DAYTIME & NIGHTTIME RELIEF VALUE PACK

Compare to active ingredients in Theraflu® Multi Symptom Severe Cold* and Nighttime Severe Cold & Cough *

MULTI- SYMPTOM

SEVERE COLD

ACETAMINOPHEN / PAIN RELIEVER/ FEVER REDUCER

DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT

PHENYLEPHRINE HCl / NASAL DECONGESTANT

DYE FREE

ASPARTAME FREE

SODIUM FREE

Relieves

Nasal congestion
Sore throat pain
Cough
Headache
Body ache
Fever

GREEN TEA & HONEY LEMON FLAVORS

INFUSED WITH MENTHOL AND GREEN TEA FLAVOR

Naturally and Artificially Flavored

 
6 MULTI-SYMPTOM PACKETS

NIGHTTIME SEVERE & COLD & COUGH

ACETAMINOPHEN/ PAIN RELIEVER/ FEVER REDUCER

DIPHENHYDRAMINE HCl / ANTIHISTAMINE/ COUGH SUPPRESSANT

PHENYLEPHRINE HCl / NASAL DECONGESTANT

ASPARTAME FREE

SODIUM FREE

Relieves

Nasal congestion
Sore throat pain
Cough
Headache
Body ache & fever
Runny nose
Sneezing

HONEY LEMON FLAVOR INFUSED WITH CHAMOMILE &WHITE TEA FLAVORS

6 NIGHTTIME PACKETS

12 TOTAL PACKETS

READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE .KEEP CARTON FOR REFERENCE, DO NOT DISCARD.

DO NOT TAKE BOTH PRODUCTS AT THE SAME TIME OR TAKE MORE THAN 5 DOSES IN TOTAL IN ANY 24 –HOUR PERIOD.

DO NOT TAKE A DOSE OF THE NIGHTTIME PRODUCT SOONER THAN 4 HOURS AFTER THE LAST DOSE OF DAYTIME PRODUCT UNLESS DIRECTED BY DOCTOR.

*These Products are not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu® Multi-Symptom Severe Cold & Theraflu® Nighttime Severe Cold & Cough.

Distributed By:

Wal-Mart Stores, Inc. Bentoville, AR 72716

© Wal-Mart Stores, Inc.

*This product is not manufactured or distributed by Novartis Consumer Health Inc., Owner of the registered trademark Gas-X®.

TAMPER EVIDENT INNER UNIT: DO NOT USE IF SEALED PACKET IS TORN OR BROKEN

Daytime and Nighttime Relief Value Pack
MULTI SYMPTOM SEVERE COLD AND NIGHTTIME SEVERE COLD AND COUGH 
acetaminophen, dextromethorphan hbr, diphenhydramine hcl, phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-948
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49035-948-121 in 1 CARTON; Type 0: Not a Combination Product07/01/2019
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 16 PACKET
Part 26 PACKET
Part 1 of 2
MULTI SYMPTOM SEVERE COLD  MULTI SYMPTOM SEVERE COLD
acetaminophen, dextromethorphan hbr, phenylephrine hcl powder, for solution
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CARAMEL (UNII: T9D99G2B1R)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SUCROSE (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
16 in 1 CARTON
11 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/01/2019
Part 2 of 2
NIGHTTIME SEVERE COLD AND COUGH  NIGHTTIME SEVERE COLD AND COUGH
acetaminophen, diphenhydramine hcl, phenylephrine hcl powder, for solution
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SUCROSE (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
16 in 1 CARTON
11 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/01/2019
Labeler - WAL-MART STORES INC (051957769)

Revised: 11/2022
 
WAL-MART STORES INC