![ALLERGY MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [CARDINAL HEALTH]](https://medic.hrt.org//dailymed/images/c5776b1e-9f72-4a6a-9961-8ac8e05b3249/leader-44-455c-ams-1.jpg)
| NDC | 70000-0211-1 |
| Set ID | c5776b1e-9f72-4a6a-9961-8ac8e05b3249 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Cardinal Health 110, LLC. DBA Leader |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist |
| Product Number | |
| Application Number | PART341 |
- Active ingredients (in each caplet)
- Purpose
-
Uses
- temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
- headache
- nasal congestion
- runny nose and sneezing
- minor aches and pains
- sinus congestion and pressure
- temporarily relieves these additional symptoms of hay fever:
- itchy, watery eyes
- itching of the nose or throat
- helps clear nasal passages
- helps decongest sinus openings and passages
- temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
-
Warnings
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:
- blisters
- rash
- skin reddening
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
- 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
- difficulty in urination due to enlargement of the prostate gland
- high blood pressure
- a breathing problem such as emphysema or chronic bronchitis
- heart disease
- thyroid disease
- diabetes
- liver disease
- glaucoma
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- do not exceed recommended dosage
- excitability may occur, especially in children
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic beverages
- use caution when driving a motor vehicle or operating machinery
- drowsiness may occur
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
LEADER™
NDC 70000-0211-1
Allergy
Multi-Symptom
Acetaminophen | Pain Reliever
Chlorpheniramine Maleate | Antihistamine
Phenylephrine HCl | Nasal DecongestantRelief of:
Headache, Sinus Pressure,
Nasal Congestion, Runny Nose,
Sneezing, Itchy, Watery EyesPseudoephedrine Free
24 CAPLETS
100% Money Back Guarantee
TAMPER EVIDENT: DO NOT USE IF
PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERINGCARDINAL HEALTH, the Cardinal Health LOGO,
LEADER, and the Leader LOGO are trademarks
or registered trademarks of Cardinal Health.100%
Money Back
GuaranteeReturn to place of purchase
if not satisfied.50844 REV0818A45508
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313
Essential to Care™ since 1979
Leader 44-455C
-
INGREDIENTS AND APPEARANCE
ALLERGY MULTI-SYMPTOM
acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0211 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) CROSPOVIDONE (UNII: 2S7830E561) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) SUCRALOSE (UNII: 96K6UQ3ZD4) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color white Score no score Shape OVAL Size 17mm Flavor MINT Imprint Code 44;455 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0211-1 2 in 1 CARTON 06/28/2005 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/28/2005 Labeler - Cardinal Health 110, LLC. DBA Leader (063997360) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(70000-0211) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(70000-0211) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(70000-0211) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 pack(70000-0211) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 pack(70000-0211)