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NDC 70000-0006-01 leader severe cold and cough 650; 25; 10 mg/1; mg/1; mg/1 Details
leader severe cold and cough 650; 25; 10 mg/1; mg/1; mg/1
leader severe cold and cough is a ORAL POWDER, FOR SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health 110, LLC. dba Leader. The primary component is ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE.
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: 70000-0006-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen
Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine 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: 70000-0006-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
Related Packages: 70000-0006-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 70000-0006 |
|---|---|
| Product ID | 70000-0006_d5f4ad88-7d96-4830-acce-d13b2b15c815 |
| Associated GPIs | 43994003903045 |
| GCN Sequence Number | 064453 |
| GCN Sequence Number Description | diphenhyd/phenyleph/acetaminop POWD PACK 25-10-650 ORAL |
| HIC3 | B3O |
| HIC3 Description | 1ST GEN ANTIHISTAMINE-DECONGESTANT-ANALGESIC COMB |
| GCN | 14359 |
| HICL Sequence Number | 035433 |
| HICL Sequence Number Description | DIPHENHYDRAMINE HCL/PHENYLEPHRINE HCL/ACETAMINOPHEN |
| Brand/Generic | Generic |
| Proprietary Name | leader severe cold and cough |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | POWDER, FOR SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 650; 25; 10 |
| Active Ingredient Units | mg/1; mg/1; mg/1 |
| Substance Name | ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | Cardinal Health 110, LLC. dba Leader |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 70000-0006-01 (70000000601)
| NDC Package Code | 70000-0006-1 |
|---|---|
| Billing NDC | 70000000601 |
| Package | 6 POWDER, FOR SOLUTION in 1 CARTON (70000-0006-1) |
| Marketing Start Date | 2019-11-13 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.48167 |
| Pricing Unit | EA |
| Effective Date | 2022-10-19 |
| NDC Description | NIGHT SEVERE COLD-COUGH PKT |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 4 |
| Classification for Rate Setting | G |
| As of Date | 2022-11-23 |
Standard Product Labeling (SPL)/Prescribing Information SPL 8f3d6da0-fe0f-43c9-bd3a-93bb555cdef7 Details
Active ingredients (in each packet)
Uses
- •
- temporarily relieves these symptoms due to a cold:
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- minor aches and pains
- •
- minor sore throat pain
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- headache
- •
- nasal and sinus congestion
- •
- runny nose
- •
- sneezing
- •
- itchy nose or throat
- •
- itchy, watery eyes due to hay fever
- •
- cough due to minor throat and bronchial irritation
- •
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
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- more than 4,000 mg of acetaminophen in 24 hours
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- 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
- •
- in a child under 12 years of age
- •
- if you have ever had an allergic reaction to this product or any of its ingredients
- •
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- •
- with any other product containing diphenhydramine, even one used on skin
- •
- 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.
Ask a doctor before use if you have
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- liver disease
- •
- heart disease
- •
- high blood pressure
- •
- thyroid disease
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- diabetes
- •
- glaucoma
- •
- trouble urinating due to an enlarged prostate gland
- •
- a breathing problem such as emphysema or chronic bronchitis
- •
- cough that occurs with too much phlegm (mucus)
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- cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
Ask a doctor or pharmacist before use if you are
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- taking sedatives or tranquilizers
- •
- taking the blood thinning drug warfarin
When using this product
- •
- do not exceed recommended dosage
- •
- avoid alcoholic drinks
- •
- marked drowsiness may occur
- •
- alcohol, sedatives, and tranquilizers may increase drowsiness
- •
- be careful when driving a motor vehicle or operating machinery
- •
- excitability may occur, especially in children
Stop use and ask a doctor if
- •
- nervousness, dizziness, or sleeplessness occurs
- •
- fever gets worse or lasts more than 3 days
- •
- redness or swelling is present
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- new symptoms occur
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- pain, cough or nasal congestion gets worse or lasts more than 7 days
- •
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
Directions
- •
- do not use more than directed (see overdose warning)
- •
- take every 4 hours, while symptoms persist. Do not take more than 5 packets in 24 hours unless directed by a doctor.
|
Age |
Dose |
|
adults and children 12 years of age and over |
one packet |
|
children under 12 years of age |
do not use |
- •
- dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes.
- •
- if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat.
Other information
Inactive ingredients
Package/Label Principal Display Panel
Nighttime Severe Cold & Cough
Acetaminophen
Diphenhydramine HCl
Phenylephrine HCl
Pain Reliever / Fever Reducer
Antihistamine / Cough Suppressant
Nasal Decongestant
Honey Lemon
Infused with White Tea Flavors
Nasal Congestion
Cough
Runny Nose
Sneezing
Body Ache
Sore Throat Pain
Headache/Fever
COMPARE TO THERAFLU® NIGHTTIME SEVERE COLD & COUGH active ingredients
6 PACKETS
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INGREDIENTS AND APPEARANCE
| LEADER SEVERE COLD AND COUGH
acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride powder, for solution |
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| Labeler - Cardinal Health 110, LLC. dba Leader (063997360) |