Cold and Flu Relief

Manufacturer
ARMY AND AIR FORCE EXCHANGE SERVICE | LNK International, Inc.
Effective date
2023-06-15
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:29:56

Label at a glance#

ProductCold and Flu Relief Daytime, Nighttime
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE
Label structure13 sections

Indications and 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)

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

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

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg


Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

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

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer
Cough suppressant
Antihistamine

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (Nighttime only)

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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)

DOSAGE & ADMINISTRATION SECTION

  • 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)

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • 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)

INACTIVE INGREDIENT SECTION

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)

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

exchange✓select™

Compare To The Active Ingredients
of Vicks® DayQuil® and NyQuil®
Cold & Flu LiquiCaps®*

DayTime
Cold & Flu Relief
MULTI-SYMPTOM

Acetaminophen,
Dextromethorphan HBr, Phenylephrine HCl

• Pain reliever / fever Reducer
• Cough Suppressant
• Nasal Decongestant
• Relieves Headache and Sore Throat

32 Liquid Caps

Non-Drowsy

Actual Size

NightTime
Cold & Flu Relief
MULTI-SYMPTOM

Acetaminophen,
Dextromethorphan HBr, Doxylamine succinate

• Pain Reliever / fever Reducer
• Cough Suppressant
• Antihistamine
• Relieves Headache and Sore Throat

16 Liquid Caps

Actual Size

48 Total Liquid Caps

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

“SATISFACTION GUARANTEED OR YOUR MONEY BACK”
Manufactured For Your Military Exchanges
Distributed by: LNK International, Inc.
Hauppauge, NY 11788
1-800-426-9391

*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

PARENTS:
Learn About Teen Medicine Abuse
www.StopMedicineAbuse.org

Exchange Select 44-730731
Exchange Select 44-730731

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55301-93155301-931-22
55301-401
55301-402

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e482eb8f-6d09-4ff4-888a-428ad6858d0817df85c9-d7fb-45e3-be2d-5e2cdc79799c2023-06-15WarningsExact identifier
spl id: e482eb8f-6d09-4ff4-888a-428ad6858d08
spl set id: 17df85c9-d7fb-45e3-be2d-5e2cdc79799c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.