ROBITUSSIN PEAK COLD DAYTIME COLD PLUS FLU- acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule, liquid filled

ROBITUSSIN PEAK COLD DAYTIME COLD PLUS FLU by

Drug Labeling and Warnings

ROBITUSSIN PEAK COLD DAYTIME COLD PLUS FLU by is a Otc medication manufactured, distributed, or labeled by Richmond Division of Wyeth. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each liquid-filled capsule)	Purposes
Acetaminophen, USP 325 mg	Pain reliever/Fever reducer
Dextromethorphan HBr, USP 10 mg	Cough suppressant
Phenylephrine HCl, USP 5 mg	Nasal decongestant

Uses

• temporarily relieves these symptoms occurring with a cold or flu:
  • headache
  • nasal congestion
  • sore throat
  • cough
  • minor aches and pains
• temporarily reduces fever

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

• more than 12 capsules in any 24-hour period, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

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.

Ask a doctor before use if you have

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• a chronic cough that lasts or as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin
• taking any other oral nasal decongestant or stimulant
• taking any other pain reliever/fever reducer

When using this product do not use more than directed

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
• cough comes back or occurs with rash or headache that lasts.
  These could be signs of a serious condition.
• new symptoms occur

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center 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 12 capsules in any 24-hour period
• do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
• this adult product is not intended for use in children under 12 years of age

age	dose
adults and children 12 years and over	2 capsules every 4 hours
children under 12 years	do not use

Other information

• store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).

Inactive ingredients

FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, mineral oil, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution

Questions or comments?

Call weekdays from 9 AM to 5 PM EST at 1-800-762-4675

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Distributed by: Pfizer, Madison, NJ 07940 USA

Made in Canada

For most recent product information, visit www.robitussin.com

PRINCIPAL DISPLAY PANEL - 20 Capsule Carton

ADULT

Robitussin®

PEAK COLD

DAYTIME

Cold + Flu

ACETAMINOPHEN (Pain Reliever / Fever Reducer)
DEXTROMETHORPHAN HBr (Cough Suppressant)
PHENYLEPHRINE HCl (Nasal Decongestant)

Relieves:

• ✔ Cough
• ✔ Body Ache
• ✔ Fever
• ✔ Sore Throat
• ✔ Nasal Congestion

Non-Drowsy

For Ages 12 & Over

20
LIQUID-FILLED
CAPSULES

INGREDIENTS AND APPEARANCE

ROBITUSSIN PEAK COLD DAYTIME COLD PLUS FLU 
acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0031-8721
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	10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K12 (UNII: 333AG72FWJ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)
MINERAL OIL (UNII: T5L8T28FGP)

Product Characteristics
Color	ORANGE (clear orange)	Score	no score
Shape	CAPSULE	Size	20mm
Flavor		Imprint Code	R
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0031-8721-20	20 in 1 CARTON
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 0031-8721-02	30 in 1 CARTON
2		2 in 1 POUCH; 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	04/15/2012

Labeler - Richmond Division of Wyeth (829390835)