Vicks ®

Vicks ®
SPL v4
SPL
SPL Set ID 81ef58de-7e65-446f-98f0-fb88027124ce
Route
ORAL
Published
Effective Date 2025-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (12.5 mg)
Inactive Ingredients
Sodium Benzoate Anhydrous Citric Acid Water Saccharin Sodium Sodium Citrate Glycerin Sorbitol Sucralose Polysorbate 20 Propylene Glycol Sodium Chloride

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-25

Description

Drug Facts

Purpose

Antihistamine/Cough suppressant


Medication Information

Purpose

Antihistamine/Cough suppressant

Description

Drug Facts

Uses
  • temporarily relieves common cold symptoms:
  • cough due to minor throat & bronchial irritation
  • cough to help you sleep
  • runny nose & sneezing
Section 34088-5

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50569-3

Ask a doctor before use if you have

  • glaucoma
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis or emphysema
Directions
  • take only as directed
  • only use the dose cup provided
  • do not exceed 4 doses per 24 hrs
 adults & children 12 yrs & over  30 mL every 4 hrs
 children 6 to under 12 yrs  15 mL every 4 hrs
 children 4 to under 6 yrs  do not use unless directed by a doctor
 children under 4 yrs  do not use

Do Not Use
  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy
Other Information
  • each 15 mL contains: sodium 44 mg
  • store at no greater than 25°C
Inactive Ingredients

anhydrous citric acid, flavor, glycerin, polysorbate 20, propylene glycol, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, water

Questions Or Comments?

1-800-362-1683

Principal Display Panel

VICKS®

NyQuil™

Kids

FREE OF

ARTIFICIAL DYES & SUGAR

COLD & COUGH + RUNNY NOSE

Diphenhydramine HCl

Sneezing, Runny Nose, Cough

AGES 6+

6 FL OZ (177 mL)

When Using This Product
  • 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
  • cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache

These could be signs of a serious condition.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Active Ingredient (in Each 15 Ml)

Diphenhydramine HCl 12.5 mg

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers


Structured Label Content

Uses
  • temporarily relieves common cold symptoms:
  • cough due to minor throat & bronchial irritation
  • cough to help you sleep
  • runny nose & sneezing
Section 34088-5 (34088-5)

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • glaucoma
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis or emphysema
Purpose

Antihistamine/Cough suppressant

Directions
  • take only as directed
  • only use the dose cup provided
  • do not exceed 4 doses per 24 hrs
 adults & children 12 yrs & over  30 mL every 4 hrs
 children 6 to under 12 yrs  15 mL every 4 hrs
 children 4 to under 6 yrs  do not use unless directed by a doctor
 children under 4 yrs  do not use

Do Not Use (Do not use)
  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy
Other Information (Other information)
  • each 15 mL contains: sodium 44 mg
  • store at no greater than 25°C
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, flavor, glycerin, polysorbate 20, propylene glycol, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, water

Questions Or Comments? (Questions or comments?)

1-800-362-1683

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

VICKS®

NyQuil™

Kids

FREE OF

ARTIFICIAL DYES & SUGAR

COLD & COUGH + RUNNY NOSE

Diphenhydramine HCl

Sneezing, Runny Nose, Cough

AGES 6+

6 FL OZ (177 mL)

When Using This Product (When using this product)
  • 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 (Stop use and ask a doctor if)
  • cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache

These could be signs of a serious condition.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Active Ingredient (in Each 15 Ml) (Active ingredient (in each 15 mL))

Diphenhydramine HCl 12.5 mg

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers


Advanced Ingredient Data


Raw Label Data

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