DAY TIME MULTI-SYMPTOM FLU COLD MEDICINE- acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled
Salado Sales, 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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CVP 44-659-Delisted

Active ingredients (in each liquid-filled capsule)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

Uses

temporarily relieves common cold and flu symptoms:
- sore throat
- minor aches and pains
- headache
- nasal congestion
- fever
- cough due to minor throat and bronchial irritation

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

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
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

When using this product

do not exceed recommended dosage.

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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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
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

Other information

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

Inactive ingredients

edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol

Questions or comments?

1-800-426-9391

Principal display panel

CVP®
HEALTH

COMPARE TO VICKS® DAYQUIL® COLD & FLU LIQUICAPS® ACTIVE INGREDIENTS*

DAY TIME
LIQUID CAPS

MULTI-SYMPTOM FLU & COLD MEDICINE

• ACETAMINOPHEN - PAIN RELIEVER/FEVER REDUCER
• DEXTROMETHORPHAN HBr - COUGH SUPPRESSANT
• PHENYLEPHRINE HCl - NASAL DECONGESTANT

12 LIQUID CAPS
ALCOHOL & ANTIHISTAMINE FREE

RELIEVES:
ACHES & PAINS
SORE THROAT
COUGH
STUFFY HEAD
FEVER SYMPTOMS
ASSOCIATED WITH THE
COMMON COLD & FLU

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademark Vicks® DayQuil® Cold & Flu LiquiCaps®.

50844 REV0418C65902

Distributed by Consumer Value Products, Inc.
P.O. Box 6115, Temple, Texas 76502
CVPproducts.com

Product of China
Packaged and Quality Assured in the USA

44-659

DAY TIME MULTI-SYMPTOM FLU COLD MEDICINE
acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57243-659
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)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	orange (clear)	Score	no score
Shape	OVAL	Size	21mm
Flavor		Imprint Code	659
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:57243-659-02	1 in 1 CARTON	03/01/2015	12/01/2022
1		12 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	03/01/2015	12/01/2022

Labeler - Salado Sales, Inc. (009830555)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(57243-659)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	pack(57243-659)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	pack(57243-659)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(57243-659)

Revised: 8/2023

Document Id: 4a26b7eb-d0de-47db-b881-7f530de0a56b

Set id: 401ad072-7e05-41bf-97e2-dbcecb82ff8e

Version: 11

Effective Time: 20230814

Salado Sales, Inc.