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  5. Label Information: Robitussin Direct Runny Nose

FDA Label for Robitussin Direct Runny Nose

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. WHEN USING THIS PRODUCT
    9. DOSAGE & ADMINISTRATION
    10. STORAGE AND HANDLING
    11. INACTIVE INGREDIENT
    12. OTC - QUESTIONS
    13. ADDITIONAL INFORMATION
    14. PRINCIPAL DISPLAY PANEL

Robitussin Direct Runny Nose Product Label

The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active ingredient (in each tablet)

Diphenhydramine HCI 25 mg


Otc - Purpose



Purpose

Antihistamine


Indications & Usage



Uses

  • •temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • •runny nose
  • •itchy, watery eyes
  • •sneezing
  •  itching of the nose or throat
  • •temporarily relieves these symptoms due to the common cold:
  • •runny nose
  • •sneezing

Warnings



Warnings


Do Not Use



  • •to make a child sleepy
  • •with any other product containing diphenhydramine, even one used on skin

Ask A Doctor Before Use If You Have



  • •glaucoma
  • •a breathing problem such as emphysema or chronic bronchitis
  • •trouble urinating due to an enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are



taking sedatives or tranquilizers


When Using This Product



  • •marked drowsiness may occur
  • •avoid alcoholic beverages
  • •alcohol, sedatives, and tranquilizers may increase drowsiness
  • •use caution when driving a motor vehicle or operating machinery
  • •excitability may occur, especially in children

Dosage & Administration



Directions

  • •do not take more than directed
  • •take every 4 to 6 hours, or as directed by a doctor
  • •do not take more than 6 times in 24 hours

    • adults and children 12 years and over

    1 to 2 tablets

    Children 6 to under 12 years

    1 tablet

    children under 6 years

    do not use


Storage And Handling



Other information

  • •each tablet contains: calcium 30 mg
  • •store at 20-25°C (68-77°F)

Inactive Ingredient



Inactive ingredients

D&C red no. 27 aluminum lake, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch,

silicon dioxide, stearic acid, talc, titanium dioxide


Otc - Questions



Questions or comments?

Call weekdays from 9 AM to 5 PM EST at 1-800-245-1040


Additional Information



Do not use if safety seal under cap printed with “Sealed for Your Protection” is broken or missing.

Lift Here for More Drug Facts

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

visit www.robitussin.com

Trademarks owned or licensed by GSK.

©2022 GSK or licensor.

Made in China


Principal Display Panel



NEW

Robitussin

Runny Nose
Diphenhydramine HCl

(Antihistamine)

direct

Actual size

18
Tablets
L-0630-329-44-UPC_ORG Front Label

Robitussin Direct Runny Nose 18 caplets - image 01

Robitussin Direct Runny Nose 18 caplets - image 01


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