good neighbor pharmacy cold and flu night time

Manufacturer
Amerisource Bergen
Effective date
2019-12-03
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:56:07

Label at a glance#

Productgood neighbor pharmacy cold and flu night time
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure16 sections

Indications and uses

• temporarily relieves these common cold and flu symptoms: • nasal congestion • headache • minor aches and pains • sore throat • runny nose and sneezing • temporarily reduces fever

Dosage and administration

• do not take more than directed (see Overdose warning) • do not take more than 10 caplets in any 24-hour period • adults and children 12 years of age and older: take 2 caplets every 4 hours • children under 12 years of age: do not use

Storage and handling

• store at 20-25 ° C (68-77 ° F) • do not use if blister unit is broken or torn

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 5 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Antihistamine

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these common cold and flu symptoms:
  • nasal congestion
  • headache
  • minor aches and pains
  • sore throat
  • runny nose and sneezing
  • temporarily reduces fever

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.
  • 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.
  • 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

  • liver disease
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

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

When using this product

OTC - WHEN USING SECTION

  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occur
  • pain or nasal congestion 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

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

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed (see Overdose warning)
  • do not take more than 10 caplets in any 24-hour period
  • adults and children 12 years of age and older: take 2 caplets every 4 hours
  • children under 12 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)
  • do not use if blister unit is broken or torn

Inactive ingredients

INACTIVE INGREDIENT SECTION

crospovidone, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Mucinex® Fast-Max® Night Time Cold & Flu active ingredients

See New Warnings

FOR AGES 12+

Cold & Flu Night Time

acetaminophen – pain reliever/fever reducer

diphenhydramine HCl – antihistamine

phenylephrine HCl – nasal decongestant

Maximum Strength

Relieves Aches, Fever & Sore Throat

Relieves Nasal Congestion

Relieves Runny Nose & Sneezing

20 Caplets

Good Neighbor Pharmacy Cold & Flu Night Time Image
Good Neighbor Pharmacy Cold & Flu Night Time Image
Good Neighbor Pharmacy Cold & Flu Night Time Imag2
Good Neighbor Pharmacy Cold & Flu Night Time Imag2
Good Neighbor Pharmacy Cold & Flu Night Time Image 3
Good Neighbor Pharmacy Cold & Flu Night Time Image 3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-268-60EA - Each46122-268ddeb9afb-eadd-4d6d-9ba1-c02ab13f401d12022-06-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
46122-26846122-268-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
2d7d4805-a5de-465a-8c3f-09fbddd101738d7ecd9c-3823-403b-9a2d-0508794326632020-12-02WarningsExact identifier
spl set id: 8d7ecd9c-3823-403b-9a2d-050879432663

Reported adverse events (FAERS/openFDA)#

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