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NDC 70000-0134-02 Cold and Flu 325; 15; 6.25 mg/1; mg/1; mg/1 Details

Cold and Flu 325; 15; 6.25 mg/1; mg/1; mg/1

Cold and Flu is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health 110, LLC. DBA Leader. The primary component is ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE.

MedlinePlus Drug Summary

Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Related Packages: 70000-0134-02
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen

Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.

Related Packages: 70000-0134-02
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dextromethorphan

Doxylamine is used in the short-term treatment of insomnia (difficulty falling asleep or staying asleep). Doxylamine is also used in combination with decongestants and other medications to relieve sneezing, runny nose, and nasal congestion caused by the common cold. Doxylamine should not be used to cause sleepiness in children. Doxylamine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Related Packages: 70000-0134-02
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Doxylamine

Product Information

NDC	70000-0134
Product ID	70000-0134_157a6420-eb33-42de-bf6b-4701866dd490
Associated GPIs	43998903350120
GCN Sequence Number	059455
GCN Sequence Number Description	DM/acetaminophen/doxylamine CAPSULE 15MG-325MG ORAL
HIC3	B4G
HIC3 Description	NON-OPIOID ANTITUS-1ST GEN ANTIHIST-ANALGESIC COMB
GCN	25094
HICL Sequence Number	025663
HICL Sequence Number Description	DEXTROMETHORPHAN HBR/ACETAMINOPHEN/DOXYLAMINE
Brand/Generic	Generic
Proprietary Name	Cold and Flu
Proprietary Name Suffix	Nighttime Multi-symptom
Non-Proprietary Name	Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE, LIQUID FILLED
Route	ORAL
Active Ingredient Strength	325; 15; 6.25
Active Ingredient Units	mg/1; mg/1; mg/1
Substance Name	ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Labeler Name	Cardinal Health 110, LLC. DBA Leader
Pharmaceutical Class	Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2023-12-31

Package

Package Images

NDC 70000-0134-02 (70000013402)

Pricing Information	N/A
NDC Package Code	70000-0134-2
Billing NDC	70000013402
Package	2 BLISTER PACK in 1 CARTON (70000-0134-2) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date	2015-03-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL bcbbb8d1-12f5-4021-a0ed-ebef3bcb5f72 Details

Active ingredients (in each liquid-filled capsule)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses

temporarily relieves common cold and flu symptoms:

sore throat
minor aches and pains
headache
fever
runny nose and sneezing
cough due to minor throat and bronchial irritation

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.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

do not take more than directed
do not take more than 8 capsules per 24 hours
adults and children 12 years and over: take 2 capsules with water every 6 hours
children under 12 years: ask a doctor

Other information

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
protect from heat, humidity and light
see end flap for expiration date and lot number

Inactive ingredients

D&C yellow #10, edible white ink, FD&C blue #1, gelatin, glycerin, lecithin, mineral oil, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol

Questions or comments?

1-800-426-9391

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 Antihistamine

Relief Of:

Headache, Fever,

Sore throat, Cough,

Sneezing, Runny Nose

24 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 TAMPERING

CardinalHealth™

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

Essential to Care™ since 1979

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Product of China

Packaged and Quality Assured in the USA

All 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 filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0134
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MINERAL OIL (UNII: T5L8T28FGP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	green (clear green)	Score	no score
Shape	OVAL	Size	21mm
Flavor		Imprint Code	660
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	03/01/2015

Labeler - Cardinal Health 110, LLC. DBA Leader (063997360)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	pack(70000-0134)

Revised: 8/2022

Document Id: 157a6420-eb33-42de-bf6b-4701866dd490

Set id: bcbbb8d1-12f5-4021-a0ed-ebef3bcb5f72

Version: 8

Effective Time: 20220827