Drug Facts
2620a150-4a2c-4fa2-a0e4-6aafe9e496c3
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Loratadine, USP 10 mg Pseudoephedrine sulfate, USP 240 mg
Purpose
Antihistamine Nasal decongestant
Medication Information
Purpose
Antihistamine
Nasal decongestant
Description
Loratadine, USP 10 mg Pseudoephedrine sulfate, USP 240 mg
Uses
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- sneezing
- itchy, watery eyes
- runny nose
- itching of the nose or throat
- reduces swelling of nasal passages
- temporarily relieves sinus congestion and pressure
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- temporarily restores freer breathing through the nose
Section 42229-5
Distributed By
MAJOR
®PHARMACEUTICALS
Indianapolis, IN 46268
(800) 616-2471
www.major-rugby.com
Directions
- do not divide, crush, chew or dissolve the tablet
| adults and children 12 years and over | 1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours |
| children under 12 years of age | ask a doctor |
| consumers with liver or kidney disease | ask a doctor |
Do Not Use
- if you have ever had an allergic reaction to this product or any of its ingredients
- 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.
Questions?
call 1-800-406-7984
Keep the carton. It contains important information.
See end panel for expiration date.
Other Information
- sodium:contains 10 mg/tablet
- calcium:contains 25 mg/tablet
- TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. (for blister cartons only)
- store between 20° C to 25° C (68° F to 77° F).
- protect from light and store in a dry place
Inactive Ingredients
calcium carbonate, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, sodium alginate, sodium citrate, talc and titanium dioxide
Stop Use and Ask A Doctor If
- an allergic reaction to this product occurs. Seek medical help right away.
- symptoms do not improve within 7 days or are accompanied by a fever
- nervousness, dizziness or sleeplessness occurs
If Pregnant Or Breast Feeding,
ask a health professional before use.
Keep Out of Reach of Children.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Active Ingredients (in Each Tablet)
Loratadine, USP 10 mg
Pseudoephedrine sulfate, USP 240 mg
Ask A Doctor Before Use If You Have
- heart disease
- thyroid disease
- high blood pressure
- diabetes
- trouble urinating due to an enlarged prostate gland
- liver or kidney disease. Your doctor should determine if you need a different dose.
When Using This Product Do Not Take More Than Directed.
Taking more than directed may cause drowsiness.
Principal Display Panel 240 Mg/10 Mg Tablet Blister Pack Carton
MAJOR ®
NDC 0904-5833-15
compare to the active ingredients in
Claritin-D
®24 Hour**
non-drowsy*
loratadine-D
original prescription strength
pseudoephedrine sulfate, USP 240 mg
nasal decongestant
loratadine, USP 10 mg
antihistamine
24 hour
indoor & outdoor allergies
allergy & congestion
relief of:
nasal and sinus congestion due to colds or allergies
sneezing; runny nose; itchy, watery eyes;
itchy throat or nose due to allergies
*when taken as directed. see drug facts panel.
10 extended-release tablets
Structured Label Content
Uses (USES)
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- sneezing
- itchy, watery eyes
- runny nose
- itching of the nose or throat
- reduces swelling of nasal passages
- temporarily relieves sinus congestion and pressure
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- temporarily restores freer breathing through the nose
Section 42229-5 (42229-5)
Distributed By
MAJOR
®PHARMACEUTICALS
Indianapolis, IN 46268
(800) 616-2471
www.major-rugby.com
Purpose (PURPOSE)
Antihistamine
Nasal decongestant
Directions (DIRECTIONS)
- do not divide, crush, chew or dissolve the tablet
| adults and children 12 years and over | 1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours |
| children under 12 years of age | ask a doctor |
| consumers with liver or kidney disease | ask a doctor |
Do Not Use (Do not use)
- if you have ever had an allergic reaction to this product or any of its ingredients
- 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.
Questions? (QUESTIONS?)
call 1-800-406-7984
Keep the carton. It contains important information.
See end panel for expiration date.
Other Information (OTHER INFORMATION)
- sodium:contains 10 mg/tablet
- calcium:contains 25 mg/tablet
- TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. (for blister cartons only)
- store between 20° C to 25° C (68° F to 77° F).
- protect from light and store in a dry place
Inactive Ingredients (INACTIVE INGREDIENTS)
calcium carbonate, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, sodium alginate, sodium citrate, talc and titanium dioxide
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
- an allergic reaction to this product occurs. Seek medical help right away.
- symptoms do not improve within 7 days or are accompanied by a fever
- nervousness, dizziness or sleeplessness occurs
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)
ask a health professional before use.
Keep Out of Reach of Children. (Keep out of reach of children.)
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Active Ingredients (in Each Tablet) (ACTIVE INGREDIENTS (IN EACH TABLET))
Loratadine, USP 10 mg
Pseudoephedrine sulfate, USP 240 mg
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
- heart disease
- thyroid disease
- high blood pressure
- diabetes
- trouble urinating due to an enlarged prostate gland
- liver or kidney disease. Your doctor should determine if you need a different dose.
When Using This Product Do Not Take More Than Directed. (When using this product do not take more than directed.)
Taking more than directed may cause drowsiness.
Principal Display Panel 240 Mg/10 Mg Tablet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 240 mg/10 mg Tablet Blister Pack Carton)
MAJOR ®
NDC 0904-5833-15
compare to the active ingredients in
Claritin-D
®24 Hour**
non-drowsy*
loratadine-D
original prescription strength
pseudoephedrine sulfate, USP 240 mg
nasal decongestant
loratadine, USP 10 mg
antihistamine
24 hour
indoor & outdoor allergies
allergy & congestion
relief of:
nasal and sinus congestion due to colds or allergies
sneezing; runny nose; itchy, watery eyes;
itchy throat or nose due to allergies
*when taken as directed. see drug facts panel.
10 extended-release tablets
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:06:56.521381 · Updated: 2026-03-14T23:10:01.237919