![COLD AND FLU NIGHTTIME MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [CARDINAL HEALTH]](https://medic.hrt.org//dailymed/images/bcbbb8d1-12f5-4021-a0ed-ebef3bcb5f72/leader-44-660-1.jpg)
| NDC | 70000-0134-1, 70000-0134-2 |
| Set ID | bcbbb8d1-12f5-4021-a0ed-ebef3bcb5f72 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Cardinal Health 110, LLC. DBA Leader |
| Generic Name | |
| Product Class | Antihistamine |
| Product Number | |
| Application Number | PART341 |
- Active ingredients (in each liquid-filled capsule)
- Purpose
- Uses
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg in 24 hours, which is the maximum daily amount
- 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
- 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
- to make a child sleepy
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if you have
- liver disease
- glaucoma
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
- difficulty in urination due to enlargement of the prostate gland
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
- avoid alcoholic beverages
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- use caution when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
- pain or cough 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
- persistent cough lasts for more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache
These could be signs of a serious condition.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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Principal display panel
LEADER™
NDC 70000-0134-2
Nighttime | Multi-Symptom
Cold & Flu Relief
Acetaminophen ι Pain Reliever / Fever Reducer
Dextromethorphan HBr ι Cough Suppressant
Doxylamine Succinate ι AntihistamineRelief Of:
Headache, Fever,
Sore throat, Cough,
Sneezing, Runny Nose24 LIQUID GELS
ACTUAL SIZE
COMPARE TO VICKS®
NYQUIL® COLD & FLU
LIQUICAPS®
active ingredients*100% Money Back Guarantee
CIN 5283825 REV. 2/17
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERINGCardinalHealth™
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313
Essential to Care™ since 1979©2017 Cardinal Health. All rights Reserved.
CARDINAL HEALTH, the Cardinal Health LOGO,
LEADER, and the Leader LOGO are trademarks
or registered trademarks of Cardinal Health.PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.orgProduct of China
Packaged and Quality Assured in the USAAll LEADER™ Brand Products Have A
100% Money Back Guarantee
Return to place of purchase if not satisfied.*This product is not manufactured or distributed by Procter & Gamble, owner
of the registered trademark Vicks® NyQuil® Cold & Flu LiquiCaps®.50844 ORG021666008
Leader 44-660
-
INGREDIENTS AND APPEARANCE
COLD AND FLU NIGHTTIME MULTI-SYMPTOM
acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0134 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) MINERAL OIL (UNII: T5L8T28FGP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITOL (UNII: 506T60A25R) GLYCERIN (UNII: PDC6A3C0OX) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) WATER (UNII: 059QF0KO0R) Product Characteristics Color green (clear green) Score no score Shape OVAL Size 21mm Flavor Imprint Code 660 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0134-2 2 in 1 CARTON 03/01/2015 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:70000-0134-1 2 in 1 CARTON 03/01/2015 04/10/2021 2 8 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 03/01/2015 Labeler - Cardinal Health 110, LLC. DBA Leader (063997360) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 pack(70000-0134)