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NDC 70000-0313-01 Leader Tussin CF 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL Details
Leader Tussin CF 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL
Leader Tussin CF is a ORAL SOLUTION 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; GUAIFENESIN; 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: 70000-0313-01Last 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: 70000-0313-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dextromethorphan
Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.
Related Packages: 70000-0313-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin
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: 70000-0313-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 70000-0313 |
|---|---|
| Product ID | 70000-0313_96048177-9113-4f78-b3a9-8a54e96f5a60 |
| Associated GPIs | 43998304100915 |
| GCN Sequence Number | 067926 |
| GCN Sequence Number Description | phenylephrine/DM/acetaminop/GG LIQUID 10-650/20 ORAL |
| HIC3 | B4P |
| HIC3 Description | NON-OPIOID ANTITUSS-DECONGESTANT-ANALGESIC-EXPECT |
| GCN | 30577 |
| HICL Sequence Number | 035445 |
| HICL Sequence Number Description | PHENYLEPHRINE HCL/DEXTROMETHORPHAN HBR/ACETAMINOPHEN/GUAIFEN |
| Brand/Generic | Generic |
| Proprietary Name | Leader Tussin CF |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 650; 20; 400; 10 |
| Active Ingredient Units | mg/20mL; mg/20mL; mg/20mL; mg/20mL |
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | Cardinal Health 110, LLC. dba Leader |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], 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 70000-0313-01 (70000031301)
| NDC Package Code | 70000-0313-1 |
|---|---|
| Billing NDC | 70000031301 |
| Package | 1 BOTTLE in 1 CARTON (70000-0313-1) / 118 mL in 1 BOTTLE |
| Marketing Start Date | 2017-06-05 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.02417 |
| Pricing Unit | ML |
| Effective Date | 2023-04-19 |
| NDC Description | TUSSIN CF MAX SEVERE M-S COLD |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 4, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
Standard Product Labeling (SPL)/Prescribing Information SPL fc1e5e59-d547-4a35-8d11-0018d0c1a449 Details
Active ingredients (in each 20 mL)
Uses
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- temporarily relieves these symptoms occurring with a cold or flu:
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- cough due to minor throat and bronchial irritation
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- nasal congestion
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- sinus congestion and pressure
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- minor aches and pains
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- sore throat
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- headache
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- temporarily reduces fever
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- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
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:
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- skin reddening
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- 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.
- •
- 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 have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
Stop use and ask a doctor if
- •
- you get nervous, dizzy or sleepless
- •
- pain, cough, or nasal congestion gets worse or lasts more than 7 days
- •
- 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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- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
Keep out of reach of children.
Directions
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- do not take more than 5 doses in any 24-hour period
- •
- do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
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- measure only with dosing cup provided
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- keep dosing cup with product
- •
- mL = milliliter
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- this adult product is not intended for use in children under 12 years of age
|
age |
dose |
|
adults and children 12 years and over |
20 mL every 4 hours |
|
children under 12 years |
do not use |
Other information
Inactive ingredients
Package/Label Principal Display Panel
Adult | Maximum Strength
Tussin CF
Severe Multi-Symptom Cough Cold + Flu CF
Acetaminophen
Dextromethorphan HBr
Guaifenesin
Phenylephrine HCl
Pain Reliever/Fever Reducer
Cough Suppressant
Expectorant
Nasal Decongestant
Ages 12 Years and Over
Relieves:
Cough, Sore Throat, Body Aches, Fever, Nasal Congestion, Chest Congestion
COMPARE TO ROBITUSSIN® MAXIMUM STRENGTH SEVERE MULTI-SYMPTOM COUGH COLD + FLU active ingredients
Non-Drowsy
100% Money Back Guarantee
4 FL OZ (118mL)
INGREDIENTS AND APPEARANCE
| LEADER TUSSIN CF
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solution |
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| Labeler - Cardinal Health 110, LLC. dba Leader (063997360) |