![TOPCARE TUSSIN CF MAX (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]](https://medic.hrt.org//dailymed/images/7f25ab4d-fa2c-4192-941f-8ded957b1436/2l9-88-tussin-cf-max.jpg)
| NDC | 36800-902-26 |
| Set ID | 7f25ab4d-fa2c-4192-941f-8ded957b1436 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Topco Associates LLC |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist |
| Product Number | |
| Application Number | PART341 |
- Active ingredients (in each 20 mL)
- Purposes
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Uses
- •
- temporarily relieves these symptoms occurring with a cold or flu, hay fever, or other respiratory allergies:
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- cough due to minor throat and bronchial irritation
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- nasal congestion
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- headache
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- sore throat
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- minor aches and pains
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- runny nose
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- sneezing
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- itchy, watery eyes
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- itching of the nose and throat
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- temporarily reduces fever
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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:
- •
- 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.
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Do not use
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- to sedate a child or to make a child sleepy
- •
- 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.
- •
- with any other product containing diphenhydramine, even one used on skin
- •
- if you have ever had an allergic reaction to this product or any of its ingredients
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Ask a doctor before use if you have
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- liver disease
- •
- heart disease
- •
- high blood pressure
- •
- thyroid disease
- •
- diabetes
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- glaucoma
- •
- trouble urinating due to an enlarged prostate gland
- •
- cough that occurs with too much phlegm (mucus)
- •
- a breathing problem such as emphysema or chronic bronchitis
- •
- persistent or chronic cough such as occurs with smoking, asthma or emphysema
- Ask a doctor or pharmacist before use if you are
- When using this product
-
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
- •
- new symptoms occur
- •
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
- If pregnant or breast-feeding,
- Keep out of reach of children.
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Directions
- •
- 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.
- •
- measure only with dosing cup provided
- •
- keep dosing cup with product
- •
- mL = milliliter
- •
- 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
- Questions or comments?
-
Package/Label Principal Display Panel
COMPARE TO ROBITUSSIN® SEVERE MULTI-SYMPTOM COUGH COLD + FLU NIGHTTIME ACTIVE INGREDIENTS
NIGHTTIME
Tussin CF Max
Multi-Symptom Cough, Cold & Flu Nighttime
PAIN RELIEVER/FEVER REDUCER-ACETAMINOPHEN
ANTIHISTAMINE/COUGH SUPPRESSANT-DIPHENHYDRAMINE HCl
NASAL DECONGESTANT-PHENYLEPHRINE HCl
MAXIMUM STRENGTH SEVERE
OUR PHARMACISTS RECOMMEND
RELIEVES:
Cough, Sore Throat
Body Aches, Fever
Nasal Congestion
Runny Nose
Adult For Ages 12 & Over
4 FL OZ (118 mL)
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INGREDIENTS AND APPEARANCE
TOPCARE TUSSIN CF MAX
acetaminophen, diphenhydramine hcl, phenylephrine hcl solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-902 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg in 20 mL DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg in 20 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 20 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color RED Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-902-26 1 in 1 CARTON 04/11/2018 1 118 mL in 1 BOTTLE; 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 04/11/2018 Labeler - Topco Associates LLC (006935977)
